Associate Director Regulatory Project Management
Associate Director Regulatory Project Management
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Salary Not Disclosed
1 Vacancy
Job Description
The Role:
As an Associate Director of Regulatory Projects you will be a forwardthinking leader driving both the strategic and operational aspects of global regulatory projects. Acting as a key strategic partner you will develop proactive regulatory plans identify innovative pathways to success and make decisive progressive decisions that align with broader organizational goals.
In this role you will be handson in managing daytoday project while maintaining a clear focus on the bigger picture to ensure regulatory milestones are achieved.
Heres What Youll Do:
Serve as a strategic partner by leading the development of forwardlooking global regulatory plans for ongoing latestage programs.
Identify innovative regulatory pathways to expedite project timelines and ensure alignment with business objectives.
Drive decisive and progressive decisionmaking in regulatory strategies ensuring timely delivery and risk mitigation.
Manage the of regulatory plans with both a handson approach and an appreciation for the broader strategic impact of decisions.
Collaborate with crossfunctional teams and senior management to align on project objectives and ensure timely submission of regulatory documents.
Lead regular status review meetings providing strategic insights to address project risks
and opportunities.
Proactively troubleshoot operational issues and implement strategic interventions to optimize regulatory processes.
Promote a culture of continuous improvement driving efficiencies and innovative approaches to regulatory project management.
Develop and present strategic reports and dashboards to senior leadership on project performance and regulatory outcomes.
Heres What Youll Bring to the Table:
Bachelors degree with minimum of 5 years of experience in leading regulatory submissions and or strong program management experience
Proven track record of being a forwardthinking planner with a strong ability to balance handson project with strategic decisionmaking.
Crossfunctional project management experience in the pharmaceutical or biotechnology industry.
Strong understanding of the regulatory submission process cGMP requirements and experience in identifying regulatory pathways for accelerated timelines.
Ability to manage multiple projects simultaneously ensuring strategic alignment and delivery within scope and deadlines.
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:
Director
Employment Type
Full-Time
