VP Regulatory Affairs Oncology INT
VP Regulatory Affairs Oncology INT
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Job Description
The Role:
As VP of Regulatory Affairs for Oncology and INT you will lead and develop the regulatory strategy for Modernas oncology and individualized neoantigen therapies programs. You will work collaboratively to articulate clear and compelling regulatory strategies highlighting risks and opportunities and leveraging the mRNA platform technology. Your leadership will be pivotal in navigating the complex interplay between the FDA EMA and other international health agencies ensuring successful registration and commercialization of oncology and INT products.
Heres What Youll Do:
Strategic Leadership: Design and execute the strategic vision for regulatory affairs in Oncology and INT ensuring alignment with Modernas global business objectives.
Regulatory Submissions: Oversee the preparation submission and approval processes for regulatory filings including IND amendments and supplements.
Regulatory Compliance: Monitor regulatory developments and provide guidance to project teams regarding the implementation of regulatory strategies.
Agency Interaction: Establish and maintain relationships with regulatory agencies respond to requests for additional data and negotiate with regulatory authorities.
Policy Development: Develop and implement regulatory policies and practices in compliance with federal and international guidelines.
Team Leadership: Manage and develop a highperforming regulatory team ensuring the team is equipped to meet regulatory milestones.
Crossfunctional Collaboration: Partner with internal teams and external partners to manage submissions and ensure regulatory compliance.
Global Regulatory Lead: Serve as the global regulatory lead accountable for all regulatory aspects of assigned projects including the development and implementation of global regulatory development plans.
Communication: Effectively communicate regulatory strategies risks and plans to the GRS project development teams and senior management.
Resource Management: Ensure appropriate levels of resources and manage the regulatory budget.
Continuous Improvement: Identify and implement process improvements to enhance regulatory practices.
Heres What Youll Bring to the Table:
BA/BS degree in a scientific/engineering discipline required; Masters or PhD preferred.
Minimum of 15 years of regulatory experience in biotech pharma or clinical research organizations with 12 years in regulatory strategy.
Indepth knowledge of relevant FDA EU ICH guidelines and regulations particularly for oncology and individualized therapies.
Proven experience with regulatory filings and negotiations with FDA and international health authorities.
Excellent communication skills and the ability to convey complex regulatory issues clearly.
Strong leadership and team management skills.
Ability to work independently and manage multiple projects in a fastpaced environment.
A desire to be part of a highgrowth transformational company that is Bold Relentless Curious and Collaborative.
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)
#LINH1Required Experience:
Exec
Employment Type
Full-Time
