Address
Form of workThe Role:
The Executive Director, CMC Regulatory Affairs will manage a team of experts including individual contributes and one-over managers responsible for regulatory CMC activities through all stages of the lifecycle for product in their portfolio. The team will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities.The Executive Director will be required to oversee the activities of the team, including review and approval of CMC and Quality related agency correspondence and regulatory applications for all the products in their portfolio. The individual will be expected to actively participate in cross-functional governance teams for topics relevant for products in their portfolio. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. The induvial will also actively lead and/or actively participate in cross-functional teams to improve and simplify complex business processes. Effective communication skills will be critical to overall success. The individual will also be responsible for mentoring and development of members of their team. The Executive Director will be based at the Norwood or Cambridge, MA site.
Heres What Youll Do:
Lead a team to develop/implement effective CMC regulatory strategies for submissions
(e.g. IND/CTA/BLA/MAA) and identify regulatory riskProvide strategic advice to manufacturing and quality teams on complex technical and regulatory CMC topics
Partner closely with senior leaders and key stakeholders to help working teams navigate emerging issues
Works collaboratively with other members of the regulatory organization to ensure alignment on regulatory strategies and priorities are aligned
Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and meet the need of the company
Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert level
Develop regulatory processes and procedures to support CMC components of regulatory submissions
Lead and/or actively participate in cross-functional teams to improve and simplify business process
Support the creation and maintenance of CMC submission templates
Provides interpretation of domestic and international regulatory guidance documents, regulations and directives advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs. Be a site expert.
Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully
Effectively manage resources to ensure business priorities are met.
Mentor and develop their team.
Heres What Youll Bring to the Table:
Minimum Qualifications
MS/PhD degree in a scientific/engineering discipline
10+ years of experience in the pharmaceutical/biotech industry
8+ years of experience in Regulatory CMC, including DMF/ASMF submissions
Strong knowledge of current US, EU, and ROW regulations
Strong experience with CTD format and content regulatory filings
Exceptional written and oral communication
Preferred Qualifications
MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable
10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
8+ years of experience in Biologics focused Regulatory CMC
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter - Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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.
By living our mission, values, and mindsets every day, our peopleare 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 in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office 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.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free 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 proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were 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. 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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