Senior Manager Global Regulatory Strategy - Combination Vaccines
Senior Manager Global Regulatory Strategy - Combination Vaccines
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Job Description
The Role:
Moderna is seeking a Sr. Manager of Regulatory Strategy to provide regulatory support for our Flu and Covid Combination programs. Based in one of Modernas East Coast hubs (Cambridge MA Bethesda MD or Princeton NJ) this role includes but is not limited to managing INDs marketing applications and other regulatory submissions (orphan drug designations pediatric plans DSURs MAA/BLA/NDA etc..
Heres What Youll Do:
Works with global regulatory lead(s) regulatory strategists Global Regulatory SubTeams and project teams regarding the development and of regulatory strategy through the product development lifecycle.
Coordinate develop and contribute to content and format of regulatory submissions and related supplements and amendments including FDA meeting requests briefing books INDs CTAs pediatric plans DSURs MAA/BLA/NDA etc.
Identify and assess regulatory risks for assigned projects or programs.
Senior Manager may serve as point of contact with regulatory agencies relevant to assigned projects or programs as appropriate.
Ability to work both independently and within project teams committees etc. to achieve group goals.
Accountable for tracking following up and archiving correspondence regulatory commitments and queries from Health Agencies.
Heres What Youll Bring to the Table:
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 Infectious Diseases and/or Biologicals is preferred
Strong knowledge of current US and EU regulations
Strong experience with CTD format and content of regulatory filings
Exceptional written and oral communication
Knowledge of and broad experience with regulatory procedures and legislation for drug development product registration line extension and license maintenancepreferably from at least both US and EU
Demonstrate strong organizational skills including the ability to prioritize workload.
Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
Experience in authoring regulatory documents
Knowledge and understanding of applicable regulations.
Experience working on products in development specifically relating to clinical and preclinical regulatory aspects of the project.
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.
- Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to wellbeing with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your wellbeing journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savings and investment opportunities
- Locationspecific perks and extras
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 worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have 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.
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at . (EEO Employer)
#LIKF1Required Experience:
Exec
Employment Type
Full-Time
