NEVAKAR INJECTABLES INC
Head of Regulatory Affairs
NEVAKAR INJECTABLES INC, Bridgewater, Massachusetts, us, 02324
Description:
Company Description
Nevakar is a privately-held, specialty pharmaceutical company committed to developing innovative products in the injectable and ophthalmic space. The company is dedicated to the development of enhanced products that address unmet clinical and/or commercial needs of current FDA approved molecules, through intensive R&D and clinical efforts. Nevakar’s drug repositioning efforts are focused on the design and development of 1) improved formulation, 2) functional packaging, 3) novel drug delivery approaches, and 4) regulatory and clinical strategies. Resulting new and repositioned products are expected to provide patient-centric benefits while ensuring incremental value proposition for the healthcare system. These new products with proprietary enhancements are filed with the FDA, primarily under the 505(b)(2) regulatory pathway.
POSITION SUMMARY
Nevakar is seeking a Head of Regulatory Affairs, to be based in Bridgewater, NJ. Reporting to the Chief Scientific Officer, this position will lead our regulatory submissions as well as preside over the company’s regulatory strategy. The position will lead the regulatory affairs and operations team as well as partner closely with the R&D, Technical Operations, and clinical development teams and external consultants to advance the company’s portfolio and ensure commercial success.
The Head of Regulatory Affairs will be a key member of management and product development leadership teams. The successful candidate will help guide the strategic direction of the development programs and assure they are designed to meet regulatory approval standards on a US and global basis.
The Head of Regulatory Affairs will be a strategic, dynamic, highly collaborative, and successful senior executive who brings significant regulatory leadership experience, from product concept, through development programs and marketed products.
The requirements for the position include a minimum of 10-15 years regulatory affairs experience as a proven leader within the pharmaceutical/bio-pharmaceutical industry or as a seasoned regulator. The successful candidate will have a notable track record of regulatory leadership. S/he will not only have the ability to identify existing regulatory pathways but also to help create, define and implement new regulatory paths that will benefit all stakeholders.
Prior experience in successful filing of regulatory submissions is required, ideally including the use of 505(b)(1), 505(b)(2) and 505(j) regulatory pathways. Candidates should have experience negotiating, filing and getting to approved registration with the FDA and Ex-US Regulatory Authorities. The successful candidate must have strong regulatory knowledge of drug development
of sterile dosage products, including R&D, CMC/manufacturing upscaling, preclinical, and clinical requirements, post-marketing surveillance, quality, marketing and sales. Pre-established relationships with the FDA and other regulatory agencies would also be ideal. Requirements:
KEY RESPONSIBILITIES
The Head of Regulatory Affairs will lead, manage and coordinate regulatory activities for the company’s portfolio in collaboration with the R&D, Technical Operations, Clinical Development, Program Management, Manufacturing, Business and Commercial teams.
The successful candidate will play a key role in developing and implementing a regulatory strategy for Nevakar’s pipeline projects and in particular help evaluate new product opportunities and manage regulatory submissions and ensure that pipeline programs are approved in a timely manner with optimal labeling. The Head of Regulatory Affairs will serve as the primary point of contact with the global regulatory agencies with responsibility for all regulatory agency submissions, action items and communications.
Specific responsibilities include:
Serve as a key member of the Executive leadership team in shaping the company’s vision and future direction.
Provide overall executive leadership and “hands on” management in creating and executing proactive regulatory strategies for product development, approval and registration, and support of future marketed products.
Lead process for filing IND/NDA and all other regulatory submissions.
Conceive of and execute strategic and creative methods for advancing regulatory goals. Strategically identify existing pathways for regulatory approval of therapeutics and also have the ability to create and implement new and better ones.
Lead the Regulatory Affairs organization by recruiting, retaining, developing and inspiring top talent. Be responsible for the Regulatory Affairs organization meeting corporate goals and objectives and keeping in compliance with applicable policies and regulations.
Form an external advisory board of regulatory counsels as required. Proactively build relationships and trust with key internal and external stakeholders and decision makers, including key influencers and decision makers on a global level.
Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion. Review and endorse key development documents (target labeling, protocols/study design, analytical plans, Risk Management Plans, Pediatric Plans, and Comparability Plans, as appropriate).
Serve as the company’s key corporate liaison and maintain strong professional relationships with key representatives of regulatory agencies, especially in the U.S. and Europe, notably the FDA and EMA. Oversee and lead the preparation of effective and persuasive presentations, negotiations and submissions of regulatory dossiers to regulatory authorities in the U.S. and internationally.
Oversee post-approval commitments and monitoring and reporting of key priorities and obligations.
Participate in the review of labeling and promotional material to ensure compliance with regulation.
Propose regulatory consultancies/advisory boards based on clear objectives; support the conduct of such meetings (preparatory material, list of questions, and communication of outcomes).
Support business development and due diligence efforts.
Remain on the forefront of the relevant science and competitive landscape including detailed competitive intelligence and be an expert in its application to the regulatory process.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
The successful candidate will have a minimum of 10-15 years of experience in regulatory affairs within the bio-pharmaceutical or pharmaceutical industry and at least 10 years of relevant North American experience. S/he should have a track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical compounds.
Specific professional experience and qualifications include:
Experience in a successful leadership role in managing a team in developing and registering candidate drugs through regulatory product approval and commercialization
Successful steering of critical (IND, NDA, MAA) filings, including negotiating, revising, and leading through submissions, approval and commercial phases and life cycle management and safety reporting. Experience with the use of 505(b)(1), 505(b)(2) and 505(j) regulatory pathways for sterile dosage forms is important.
Creates a culture of performance and accountability in an organization. Translates over-arching goals into specific objectives and holds people accountable for results. Stays focused on the most important metrics that drive the business.
Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage regulators on new approaches and implement new strategies for product regulatory filings.
Ability to build and maintain key external relationships across regulatory agencies and key stake holders. Ability to present effectively to groups and manage through others to ensure adherence to the highest quality standards, with the ability to collaborate and drive for results.
Demonstrated track record of building and leading high-performance and highly collaborative regulatory teams. Actively involved in sourcing, selecting, developing, and retaining high-performance talent for key regulatory functional leadership positions.
Ability to cultivate a high achievement organization; effective as a mentor and coach; able to attract, develop, motivate and retain key talent.
Experience working with R&D and commercial leadership teams. Diverse and sufficient technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, market access specialists, legal, etc.).
Significant direct experience in dealing with FDA, EMA and other regulatory agencies. Familiarity with the intricacies and nuances of the regulatory agencies, as well as the decision-makers within the agencies.
Broad knowledge of the regulatory and competitive environment across key regions, and anticipation of future trends and impact.
Strong understanding of the drug development process.
Stature, experience, technical credibility, strong relationship management and interpersonal skills to quickly gain confidence both with internal stakeholders (CMC, preclinical, statistics, business development, legal, etc.) and externally among regulatory agencies. An individual who can influence strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers and staff.
An individual who demonstrates humility, good judgment and strong analytical skills and adjusts quickly to changes.
Excellent organizational and project management skills and ability to think strategically.
Outstanding presentation, written and oral communication skills required. A clear communicator who can influence effectively both internally and externally.
A leader with the highest integrity, who can adapt into the environment, operate as part of an effective team, listen well and make important decisions.
EDUCATION
A higher degree, such as an MD or PhD, in pharmacy, chemistry, biology or related sciences is required.
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Nevakar is a privately-held, specialty pharmaceutical company committed to developing innovative products in the injectable and ophthalmic space. The company is dedicated to the development of enhanced products that address unmet clinical and/or commercial needs of current FDA approved molecules, through intensive R&D and clinical efforts. Nevakar’s drug repositioning efforts are focused on the design and development of 1) improved formulation, 2) functional packaging, 3) novel drug delivery approaches, and 4) regulatory and clinical strategies. Resulting new and repositioned products are expected to provide patient-centric benefits while ensuring incremental value proposition for the healthcare system. These new products with proprietary enhancements are filed with the FDA, primarily under the 505(b)(2) regulatory pathway.
POSITION SUMMARY
Nevakar is seeking a Head of Regulatory Affairs, to be based in Bridgewater, NJ. Reporting to the Chief Scientific Officer, this position will lead our regulatory submissions as well as preside over the company’s regulatory strategy. The position will lead the regulatory affairs and operations team as well as partner closely with the R&D, Technical Operations, and clinical development teams and external consultants to advance the company’s portfolio and ensure commercial success.
The Head of Regulatory Affairs will be a key member of management and product development leadership teams. The successful candidate will help guide the strategic direction of the development programs and assure they are designed to meet regulatory approval standards on a US and global basis.
The Head of Regulatory Affairs will be a strategic, dynamic, highly collaborative, and successful senior executive who brings significant regulatory leadership experience, from product concept, through development programs and marketed products.
The requirements for the position include a minimum of 10-15 years regulatory affairs experience as a proven leader within the pharmaceutical/bio-pharmaceutical industry or as a seasoned regulator. The successful candidate will have a notable track record of regulatory leadership. S/he will not only have the ability to identify existing regulatory pathways but also to help create, define and implement new regulatory paths that will benefit all stakeholders.
Prior experience in successful filing of regulatory submissions is required, ideally including the use of 505(b)(1), 505(b)(2) and 505(j) regulatory pathways. Candidates should have experience negotiating, filing and getting to approved registration with the FDA and Ex-US Regulatory Authorities. The successful candidate must have strong regulatory knowledge of drug development
of sterile dosage products, including R&D, CMC/manufacturing upscaling, preclinical, and clinical requirements, post-marketing surveillance, quality, marketing and sales. Pre-established relationships with the FDA and other regulatory agencies would also be ideal. Requirements:
KEY RESPONSIBILITIES
The Head of Regulatory Affairs will lead, manage and coordinate regulatory activities for the company’s portfolio in collaboration with the R&D, Technical Operations, Clinical Development, Program Management, Manufacturing, Business and Commercial teams.
The successful candidate will play a key role in developing and implementing a regulatory strategy for Nevakar’s pipeline projects and in particular help evaluate new product opportunities and manage regulatory submissions and ensure that pipeline programs are approved in a timely manner with optimal labeling. The Head of Regulatory Affairs will serve as the primary point of contact with the global regulatory agencies with responsibility for all regulatory agency submissions, action items and communications.
Specific responsibilities include:
Serve as a key member of the Executive leadership team in shaping the company’s vision and future direction.
Provide overall executive leadership and “hands on” management in creating and executing proactive regulatory strategies for product development, approval and registration, and support of future marketed products.
Lead process for filing IND/NDA and all other regulatory submissions.
Conceive of and execute strategic and creative methods for advancing regulatory goals. Strategically identify existing pathways for regulatory approval of therapeutics and also have the ability to create and implement new and better ones.
Lead the Regulatory Affairs organization by recruiting, retaining, developing and inspiring top talent. Be responsible for the Regulatory Affairs organization meeting corporate goals and objectives and keeping in compliance with applicable policies and regulations.
Form an external advisory board of regulatory counsels as required. Proactively build relationships and trust with key internal and external stakeholders and decision makers, including key influencers and decision makers on a global level.
Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion. Review and endorse key development documents (target labeling, protocols/study design, analytical plans, Risk Management Plans, Pediatric Plans, and Comparability Plans, as appropriate).
Serve as the company’s key corporate liaison and maintain strong professional relationships with key representatives of regulatory agencies, especially in the U.S. and Europe, notably the FDA and EMA. Oversee and lead the preparation of effective and persuasive presentations, negotiations and submissions of regulatory dossiers to regulatory authorities in the U.S. and internationally.
Oversee post-approval commitments and monitoring and reporting of key priorities and obligations.
Participate in the review of labeling and promotional material to ensure compliance with regulation.
Propose regulatory consultancies/advisory boards based on clear objectives; support the conduct of such meetings (preparatory material, list of questions, and communication of outcomes).
Support business development and due diligence efforts.
Remain on the forefront of the relevant science and competitive landscape including detailed competitive intelligence and be an expert in its application to the regulatory process.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
The successful candidate will have a minimum of 10-15 years of experience in regulatory affairs within the bio-pharmaceutical or pharmaceutical industry and at least 10 years of relevant North American experience. S/he should have a track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical compounds.
Specific professional experience and qualifications include:
Experience in a successful leadership role in managing a team in developing and registering candidate drugs through regulatory product approval and commercialization
Successful steering of critical (IND, NDA, MAA) filings, including negotiating, revising, and leading through submissions, approval and commercial phases and life cycle management and safety reporting. Experience with the use of 505(b)(1), 505(b)(2) and 505(j) regulatory pathways for sterile dosage forms is important.
Creates a culture of performance and accountability in an organization. Translates over-arching goals into specific objectives and holds people accountable for results. Stays focused on the most important metrics that drive the business.
Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage regulators on new approaches and implement new strategies for product regulatory filings.
Ability to build and maintain key external relationships across regulatory agencies and key stake holders. Ability to present effectively to groups and manage through others to ensure adherence to the highest quality standards, with the ability to collaborate and drive for results.
Demonstrated track record of building and leading high-performance and highly collaborative regulatory teams. Actively involved in sourcing, selecting, developing, and retaining high-performance talent for key regulatory functional leadership positions.
Ability to cultivate a high achievement organization; effective as a mentor and coach; able to attract, develop, motivate and retain key talent.
Experience working with R&D and commercial leadership teams. Diverse and sufficient technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, market access specialists, legal, etc.).
Significant direct experience in dealing with FDA, EMA and other regulatory agencies. Familiarity with the intricacies and nuances of the regulatory agencies, as well as the decision-makers within the agencies.
Broad knowledge of the regulatory and competitive environment across key regions, and anticipation of future trends and impact.
Strong understanding of the drug development process.
Stature, experience, technical credibility, strong relationship management and interpersonal skills to quickly gain confidence both with internal stakeholders (CMC, preclinical, statistics, business development, legal, etc.) and externally among regulatory agencies. An individual who can influence strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers and staff.
An individual who demonstrates humility, good judgment and strong analytical skills and adjusts quickly to changes.
Excellent organizational and project management skills and ability to think strategically.
Outstanding presentation, written and oral communication skills required. A clear communicator who can influence effectively both internally and externally.
A leader with the highest integrity, who can adapt into the environment, operate as part of an effective team, listen well and make important decisions.
EDUCATION
A higher degree, such as an MD or PhD, in pharmacy, chemistry, biology or related sciences is required.
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