RPMGlobal
Director, Regulatory Affairs
RPMGlobal, New York, New York, United States,
T he Role:
The Agenus Regulatory team is seeking a motivated, resourceful, and collaborative team member to join the team. This candidate should be able to work cross-functionally, and complete assigned tasks independently with guidance from the Global Head, Regulatory to ensure Agenus adheres to global regulations.
The Director of Regulatory Affairs will develop and implement regulatory strategies for all assets in all stages including IND, NDA, and Lice Cycle Management activities across the Agenus portfolio. Reporting to the Global Head of Regulatory, the candidate must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential.
In the role you will:
Develop and implements regulatory strategies and contingencies for global product development (investigational, licensing/registration, and post-marketing support).
Participate in team meetings to provide regulatory support and guidance.
Provide guidance and expertise to senior management and other departments on all regulatory issues for the strategic development, planning, compilation and submission for all regulatory filings.
Provide timely and effective communication updates on regulatory interactions to senior management and other internal stakeholders, as appropriate.
Serve as the primary contact and liaise, negotiate and orchestrate with Health Authorities.
Lead key health authority meetings, as needed, that could impact global product strategy.
Edit or lead the editing of regulatory documentation based upon regulatory requirements and Company SOPs.
Ensure compliance with existing regulatory applications (e.g. IND/CTA Maintenance).
Assist with the preparation, writing and review of regulatory documents.
Oversee late-stage development applications and marketing approved product applications.
Work with partner company counterparts to support pharma partner requirements.
Provide support on labeling and advertising matters.
Interface with contractors, vendors and consultants.
Maintain knowledge of regulatory environment, global regulations and guidance.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Qualifications: About You:
BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree preferred.
10 years of drug development experience inclusive of a minimum of 5 years in regulatory affairs with roles increasing in scope
Strong knowledge of worldwide drug development and regulatory policy; demonstrated excellent judgement in Regulatory-focused drug development.
Demonstrated ability to interpret and understand US regulations governing pharmaceutical industry.
Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.
Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across organization.
Prior experience with FDA and EMA submissions required.
Ability to critically review regulatory scientific documents across non-clinical and clinical
Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes in order to create the most efficient and effective methods to deliver quality clinical trial services.
Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
Strong leadership skills in leading team members and vendors.
Strong organizational, communication and interpersonal skills
Ability to prioritize, delegate and execute to meet project deadlines.
At ease in start-up environment and effectiveness to deliver in low-structured environments.
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The Agenus Regulatory team is seeking a motivated, resourceful, and collaborative team member to join the team. This candidate should be able to work cross-functionally, and complete assigned tasks independently with guidance from the Global Head, Regulatory to ensure Agenus adheres to global regulations.
The Director of Regulatory Affairs will develop and implement regulatory strategies for all assets in all stages including IND, NDA, and Lice Cycle Management activities across the Agenus portfolio. Reporting to the Global Head of Regulatory, the candidate must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential.
In the role you will:
Develop and implements regulatory strategies and contingencies for global product development (investigational, licensing/registration, and post-marketing support).
Participate in team meetings to provide regulatory support and guidance.
Provide guidance and expertise to senior management and other departments on all regulatory issues for the strategic development, planning, compilation and submission for all regulatory filings.
Provide timely and effective communication updates on regulatory interactions to senior management and other internal stakeholders, as appropriate.
Serve as the primary contact and liaise, negotiate and orchestrate with Health Authorities.
Lead key health authority meetings, as needed, that could impact global product strategy.
Edit or lead the editing of regulatory documentation based upon regulatory requirements and Company SOPs.
Ensure compliance with existing regulatory applications (e.g. IND/CTA Maintenance).
Assist with the preparation, writing and review of regulatory documents.
Oversee late-stage development applications and marketing approved product applications.
Work with partner company counterparts to support pharma partner requirements.
Provide support on labeling and advertising matters.
Interface with contractors, vendors and consultants.
Maintain knowledge of regulatory environment, global regulations and guidance.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Qualifications: About You:
BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree preferred.
10 years of drug development experience inclusive of a minimum of 5 years in regulatory affairs with roles increasing in scope
Strong knowledge of worldwide drug development and regulatory policy; demonstrated excellent judgement in Regulatory-focused drug development.
Demonstrated ability to interpret and understand US regulations governing pharmaceutical industry.
Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.
Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across organization.
Prior experience with FDA and EMA submissions required.
Ability to critically review regulatory scientific documents across non-clinical and clinical
Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes in order to create the most efficient and effective methods to deliver quality clinical trial services.
Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
Strong leadership skills in leading team members and vendors.
Strong organizational, communication and interpersonal skills
Ability to prioritize, delegate and execute to meet project deadlines.
At ease in start-up environment and effectiveness to deliver in low-structured environments.
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