Moderna Therapeutics
Sr. Manager, Regulatory Strategy
Moderna Therapeutics, Trenton, New Jersey, United States,
Sr. Manager, Regulatory Strategy
Moderna Therapeutics is seeking a Sr. Manager of Regulatory Strategy based in Cambridge headquarters. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug modality. The Sr. Manager will provide regulatory support for Oncology. Their support includes but is not limited to managing the submissions and approvals of INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.)Here’s What You’ll Do:Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.Works with RA-Strategist and project teams regarding the development and execution of regulatory strategy through the clinical development processes.Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.Contact regulatory agencies relevant to assigned projects or programs, as appropriate.Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).Contribute, maintain the Core Data Sheet and support global labeling team meetings.Ability to work both independently and within project teams, committees, etc. to achieve group goals.Here’s What You’ll Be Doing:BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.5+ years of experience in the Pharmaceutical industry preferred.3+ years of experience in Regulatory strategy or relevant training/experience preferred.Experience in Oncology is strongly preferred.Strong knowledge of current US and EU regulations.Strong experience with CTD format and content of regulatory filings.Exceptional written and oral communication.Experience with developing and implementing gap analysis and related competitive regulatory strategies.Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EU.Demonstrate strong organizational skills, including the ability to prioritize workload.Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.Knowledge and understanding of applicable regulations.Experience in interpretation of regulations, guidelines, policy statements, etc.Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.Salary and Benefits:Under Washington State law, Moderna is required to provide a reasonable estimate of the salary range for the jobs covered by this description. Base compensation for these positions in Washington State range from $125,500 to $201,000. Actual salary determinations will take into account factors such as work location, prior education and experience, job-related knowledge, and demonstrated skills. Compensation decisions are made on the facts and circumstances of each case.In addition to base compensation Moderna employees are eligible for a comprehensive incentive compensation package including an annual cash bonus, new hire equity and an annual refresh, 401(k) match, competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts for medical and dependent care, Life, LTD, and STD insurance, paid family leave offerings, including at least 18 weeks of 100% paid parental leave, lifestyle spending account, adoption, surrogacy, and family-planning benefits, generous paid time off, including vacation, sick time, and observed Company-wide holidays.About Moderna:Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.
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Moderna Therapeutics is seeking a Sr. Manager of Regulatory Strategy based in Cambridge headquarters. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug modality. The Sr. Manager will provide regulatory support for Oncology. Their support includes but is not limited to managing the submissions and approvals of INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.)Here’s What You’ll Do:Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.Works with RA-Strategist and project teams regarding the development and execution of regulatory strategy through the clinical development processes.Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.Contact regulatory agencies relevant to assigned projects or programs, as appropriate.Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).Contribute, maintain the Core Data Sheet and support global labeling team meetings.Ability to work both independently and within project teams, committees, etc. to achieve group goals.Here’s What You’ll Be Doing:BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.5+ years of experience in the Pharmaceutical industry preferred.3+ years of experience in Regulatory strategy or relevant training/experience preferred.Experience in Oncology is strongly preferred.Strong knowledge of current US and EU regulations.Strong experience with CTD format and content of regulatory filings.Exceptional written and oral communication.Experience with developing and implementing gap analysis and related competitive regulatory strategies.Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EU.Demonstrate strong organizational skills, including the ability to prioritize workload.Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.Knowledge and understanding of applicable regulations.Experience in interpretation of regulations, guidelines, policy statements, etc.Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.Salary and Benefits:Under Washington State law, Moderna is required to provide a reasonable estimate of the salary range for the jobs covered by this description. Base compensation for these positions in Washington State range from $125,500 to $201,000. Actual salary determinations will take into account factors such as work location, prior education and experience, job-related knowledge, and demonstrated skills. Compensation decisions are made on the facts and circumstances of each case.In addition to base compensation Moderna employees are eligible for a comprehensive incentive compensation package including an annual cash bonus, new hire equity and an annual refresh, 401(k) match, competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts for medical and dependent care, Life, LTD, and STD insurance, paid family leave offerings, including at least 18 weeks of 100% paid parental leave, lifestyle spending account, adoption, surrogacy, and family-planning benefits, generous paid time off, including vacation, sick time, and observed Company-wide holidays.About Moderna:Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.
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