Manager/Sr. Manager, Regulatory Strategy - Infectious Disease 6/6/2020
JOB DESCRIPTIONAPPLY THE ROLE:
Moderna Therapeutics is seeking a Manager/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 Manager/Sr. Manager will provide regulatory support across the Therapeutic Areas including Infectious Diseases. 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 BRING TO THE TABLE:
* BA/BS degree in a scientific/engineering discipline required, Masters or PhD preferred.
* 5+ years of experience in the Pharmaceutical industry
* 3+ years of experience in Regulatory strategy, including specifically: Infectious Disease and Vaccine Development
* Strong knowledge of current US and EU regulations, including vaccine regulatory pathways.
* Strong experience with CTD format and content 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 personal and direct reports 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.
HERE S WHAT WE LL BRING TO THE TABLE:
* On-site subsidized cafeteria or catered lunches
* Company-provided iPhone
* Free parking, monthly subway pass or a subsidized commuter rail pass
* Free annual corporate membership to Bluebikes
* Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
* Flexible Spending Accounts for medical expenses and dependent care expenses
* 16 weeks of 100% paid parental leave for all new parents
* 16 weeks 100% paid family caregiver leave
* 20 weeks 100% paid medical leave
* Eligible for Moderna Month ? (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
* Adoption assistance and discounts to local childcare centers, as well as access to care.com
* 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
* A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
* Voluntary legal assistance plan
* 15 days vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.