BioSpace
Associate Director, Global Regulatory Strategy, Oncology
BioSpace, Cambridge, Massachusetts, us, 02140
Overview
Moderna Therapeutics is seeking an
Associate Director of Regulatory Strategy
to support programs within the oncology franchise in one of Moderna’s US offices. This role is for a forward‑looking, creative and agile regulatory strategist able to anticipate and address challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology in the US and other global markets.
Responsibilities
Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading Global Regulatory Sub-teams with support from the GRL.
Set strategic direction for the US market, in collaboration with the global product strategy and project teams for assigned programs.
Ensure the US regulatory strategy aligns with the global strategy, including for IND submissions.
Lead the strategy for US FDA interactions with the cross-functional team, including development of content, format and accountability for regulatory submissions and related supplements and amendments, FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, etc.
Conduct risk assessment and identify potential regulatory concerns for assigned projects; respond to evolving health authority regulations and requirements.
Lead the response to health authority requests for additional data; organize and manage participation in meetings relevant to compound development.
Review and may approve regulatory documents prior to submission to regulatory authorities.
Serve as primary point of contact and negotiate directly with FDA and other health agencies for assigned programs.
May serve as regulatory affairs representative to provide input on clinical trials and filing activities and ensure reporting systems are maintained and compliant.
Identify areas for improvement and lead the development and implementation of process improvements.
Qualifications
BA/BS in a scientific/engineering/healthcare discipline required; Masters, PharmD or PhD preferred.
7+ years of experience in the pharmaceutical industry preferred.
5+ years of experience in regulatory strategy or relevant training/experience preferred.
Experience in oncology therapeutics highly preferred.
Demonstrated track record as a leader on functional and cross-functional teams.
Strong knowledge of current US regulations and knowledge of ex-US regulations.
Strong experience with CTD format and content of regulatory filings.
Exceptional written and oral communication skills.
Knowledge and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance (at least in the US).
Strong organizational skills and ability to prioritize workload.
Experience in developing regulatory strategies at various points in drug development.
Experience and knowledge in preparation of regulatory submissions and amendments or supplements.
Experience in authoring regulatory documents and understanding applicable regulations.
Experience working on products across all stages of development.
Benefits
Best-in-class healthcare coverage; a suite of voluntary benefits to support individual needs.
Well-being resources including fitness, mindfulness, and mental health support.
Lifestyle Spending Accounts to personalize well-being.
Family planning and adoption benefits.
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
Savings and investment opportunities.
Location-specific perks and extras.
About Moderna Since 2010, Moderna has aspired to build the leading mRNA technology platform, support the infrastructure to reimagine how medicines are created and delivered, and attract a world-class team. Moderna values a platform for employees to contribute to advancing medicine and improving patient outcomes. Moderna has been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. For more information, visit modernatx.com/careers.
Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States.
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Associate Director of Regulatory Strategy
to support programs within the oncology franchise in one of Moderna’s US offices. This role is for a forward‑looking, creative and agile regulatory strategist able to anticipate and address challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology in the US and other global markets.
Responsibilities
Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading Global Regulatory Sub-teams with support from the GRL.
Set strategic direction for the US market, in collaboration with the global product strategy and project teams for assigned programs.
Ensure the US regulatory strategy aligns with the global strategy, including for IND submissions.
Lead the strategy for US FDA interactions with the cross-functional team, including development of content, format and accountability for regulatory submissions and related supplements and amendments, FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, etc.
Conduct risk assessment and identify potential regulatory concerns for assigned projects; respond to evolving health authority regulations and requirements.
Lead the response to health authority requests for additional data; organize and manage participation in meetings relevant to compound development.
Review and may approve regulatory documents prior to submission to regulatory authorities.
Serve as primary point of contact and negotiate directly with FDA and other health agencies for assigned programs.
May serve as regulatory affairs representative to provide input on clinical trials and filing activities and ensure reporting systems are maintained and compliant.
Identify areas for improvement and lead the development and implementation of process improvements.
Qualifications
BA/BS in a scientific/engineering/healthcare discipline required; Masters, PharmD or PhD preferred.
7+ years of experience in the pharmaceutical industry preferred.
5+ years of experience in regulatory strategy or relevant training/experience preferred.
Experience in oncology therapeutics highly preferred.
Demonstrated track record as a leader on functional and cross-functional teams.
Strong knowledge of current US regulations and knowledge of ex-US regulations.
Strong experience with CTD format and content of regulatory filings.
Exceptional written and oral communication skills.
Knowledge and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance (at least in the US).
Strong organizational skills and ability to prioritize workload.
Experience in developing regulatory strategies at various points in drug development.
Experience and knowledge in preparation of regulatory submissions and amendments or supplements.
Experience in authoring regulatory documents and understanding applicable regulations.
Experience working on products across all stages of development.
Benefits
Best-in-class healthcare coverage; a suite of voluntary benefits to support individual needs.
Well-being resources including fitness, mindfulness, and mental health support.
Lifestyle Spending Accounts to personalize well-being.
Family planning and adoption benefits.
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
Savings and investment opportunities.
Location-specific perks and extras.
About Moderna Since 2010, Moderna has aspired to build the leading mRNA technology platform, support the infrastructure to reimagine how medicines are created and delivered, and attract a world-class team. Moderna values a platform for employees to contribute to advancing medicine and improving patient outcomes. Moderna has been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. For more information, visit modernatx.com/careers.
Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States.
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