Associate Director Global Regulatory Strategy Oncology
Associate Director Global Regulatory Strategy Oncology
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Job Description
The Role:
Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise to be based in one of Modernas US offices. This is a role intended for a forward looking creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology an unprecedented new drug modality in the US and other global markets.
The Associate Director will be a strategic leader within the Global Regulatory Strategy Oncology group. They will be responsible for developing and executing regulatory plans for the US market and exUS regions for assigned programs at various stages of product development. They will be relied upon to articulate clear and compelling regulatory strategy and highlighting risks and opportunities when appropriate. Prior regulatory experience with oncology drug development is strongly desired.
Heres What Youll Do:
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 the Global Regulatory Subteams with support from the GRL
Sets strategic direction for the US market in collaboration and alignment with the global product strategy with GRL Global Regulatory SubTeams and project teams for assigned programs.
Ensures the US regulatory strategy is aligned with the global strategy for assigned programs including for investigational new drug application submissions.
Leads 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.
Conducts risk assessment and identifies potential areas of regulatory concern for assigned projects or programs and responds to emerging health authority regulations and requirements.
In collaboration with the cross functional team leads the response to health authority requests for additional data organizes and manages participation in meetings relevant to aspects of compound development
Reviews and may approve regulatory documents prior to submission to respective regulatory authority(ies).
Serves as primary point of contact and negotiates directly and effectively 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 to ensure that report systems are maintained and compliant.
Identify areas in need of improvement and lead the development and implementation of process improvements.
Heres What Youll Bring to the Table:
BA/BS degree 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 in being a leader on functional and crossfunctional teams
Strong knowledge of current US regulations and knowledge of exUS 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 maintenance at least in the US
Demonstrate strong organizational skills including the ability to prioritize workload.
Experience in developing regulatory strategies at various drug development time points
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 across all stages of product development.
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
