Actalent
Head Of Regulatory Affairs
Actalent, Bridgewater, New Jersey, us, 08807
Job Title: Head of Regulatory AffairsJob Description
We are 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 and partner closely with the R&D, Technical Operations, and clinical development teams, along with external consultants. The Head of Regulatory Affairs will be a key member of management and product development leadership teams, guiding the strategic direction of development programs to meet regulatory approval standards on both US and global bases.
Responsibilities
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.
Develop and implement a regulatory strategy for pipeline projects, evaluate new product opportunities, and manage regulatory submissions.
Serve as the primary point of contact with global regulatory agencies, handling all regulatory submissions, action items, and communications.
Provide executive leadership and hands-on management in creating and executing proactive regulatory strategies for product development, approval, and registration.
Lead the process for filing IND/NDA and all other regulatory submissions.
Identify existing regulatory pathways and create new, beneficial regulatory paths.
Recruit, retain, develop, and inspire top talent within the Regulatory Affairs organization.
Form an external advisory board of regulatory counsels as required and build relationships with key internal and external stakeholders.
Develop and implement regulatory strategies, including regulatory risk management, and ensure timely resolution of RA issues.
Serve as the company’s key corporate liaison, maintaining strong professional relationships with regulatory agencies, especially the FDA and EMA.
Oversee and lead the preparation of effective presentations, negotiations, and submissions of regulatory dossiers to regulatory authorities.
Essential Skills
Minimum of 10-15 years of experience in regulatory affairs within the bio-pharmaceutical or pharmaceutical industry.
At least 10 years of relevant North American experience.
Proven track record of successful interaction with regulatory agencies, demonstrated by timely submissions and approvals of pharmaceutical compounds.
Experience in successful filing of regulatory submissions, including the use of 505(b)(1), 505(b)(2), and 505(j) regulatory pathways.
Strong regulatory knowledge of drug development for 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.
Additional Skills & Qualifications
MD or PhD in pharmacy, chemistry, biology, or related sciences.
Experience with 505(2)(b) registration pathway.
Ability to conceive and execute strategic and creative methods for advancing regulatory goals.
Strong leadership and team management skills.
Work Environment
The company 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 through intensive R&D and clinical efforts. The drug repositioning efforts focus on improved formulation, functional packaging, novel drug delivery approaches, and regulatory and clinical strategies. The therapeutic focus is on the clinical development of ophthalmic treatments for disease states with limited treatment options. The company has a growing pipeline with a strong emphasis on ophthalmic treatments and is on the brink of a product approval, which would be significant for employees who earn company equity. The environment is dynamic and collaborative, with a strong injectable pipeline aimed to expand significantly.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
We are 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 and partner closely with the R&D, Technical Operations, and clinical development teams, along with external consultants. The Head of Regulatory Affairs will be a key member of management and product development leadership teams, guiding the strategic direction of development programs to meet regulatory approval standards on both US and global bases.
Responsibilities
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.
Develop and implement a regulatory strategy for pipeline projects, evaluate new product opportunities, and manage regulatory submissions.
Serve as the primary point of contact with global regulatory agencies, handling all regulatory submissions, action items, and communications.
Provide executive leadership and hands-on management in creating and executing proactive regulatory strategies for product development, approval, and registration.
Lead the process for filing IND/NDA and all other regulatory submissions.
Identify existing regulatory pathways and create new, beneficial regulatory paths.
Recruit, retain, develop, and inspire top talent within the Regulatory Affairs organization.
Form an external advisory board of regulatory counsels as required and build relationships with key internal and external stakeholders.
Develop and implement regulatory strategies, including regulatory risk management, and ensure timely resolution of RA issues.
Serve as the company’s key corporate liaison, maintaining strong professional relationships with regulatory agencies, especially the FDA and EMA.
Oversee and lead the preparation of effective presentations, negotiations, and submissions of regulatory dossiers to regulatory authorities.
Essential Skills
Minimum of 10-15 years of experience in regulatory affairs within the bio-pharmaceutical or pharmaceutical industry.
At least 10 years of relevant North American experience.
Proven track record of successful interaction with regulatory agencies, demonstrated by timely submissions and approvals of pharmaceutical compounds.
Experience in successful filing of regulatory submissions, including the use of 505(b)(1), 505(b)(2), and 505(j) regulatory pathways.
Strong regulatory knowledge of drug development for 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.
Additional Skills & Qualifications
MD or PhD in pharmacy, chemistry, biology, or related sciences.
Experience with 505(2)(b) registration pathway.
Ability to conceive and execute strategic and creative methods for advancing regulatory goals.
Strong leadership and team management skills.
Work Environment
The company 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 through intensive R&D and clinical efforts. The drug repositioning efforts focus on improved formulation, functional packaging, novel drug delivery approaches, and regulatory and clinical strategies. The therapeutic focus is on the clinical development of ophthalmic treatments for disease states with limited treatment options. The company has a growing pipeline with a strong emphasis on ophthalmic treatments and is on the brink of a product approval, which would be significant for employees who earn company equity. The environment is dynamic and collaborative, with a strong injectable pipeline aimed to expand significantly.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.