Senior Manager Regulatory Project Management Global Regulatory CMC
Senior Manager Regulatory Project Management Global Regulatory CMC
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1 Vacancy
Job Description
The Role:
We are seeking an experienced and dynamic Regulatory CMC Project Senior Manager to join our team. In this role you will manage regulatory submissions related to Chemistry Manufacturing and Controls (CMC) for the development and commercialization of biopharmaceuticals biologics or small molecules. You will lead crossfunctional teams to ensure timely highquality regulatory submissions and approvals and manage project timelines and submissionrelated processes.
The ideal candidate will have a strong background in CMC regulatory submissions project management and a deep understanding of global regulatory submission frameworks (FDA EMA ICH etc.. You will be instrumental in supporting the launch of innovative therapies and ensuring that they meet both internal and regulatory standards across multiple markets.
Heres What Youll Do:
Regulatory CMC Project Management:
Lead and oversee the tactical management of CMC regulatory submissions for assigned drug development programs.
Ensure the successful of regulatory submission milestones for CMC documentation including Investigational New Drug (IND) applications Biologics License Applications (BLA) Marketing Authorization Applications (MAA) and variations.
Regulatory Submissions & Documentation:
Manage the preparation review and submission of CMC sections for regulatory filings (IND CTA NDA MAA BLA etc. in compliance with global regulatory requirements and support the integration of project plans.
Coordinate regulatory responses to Health Authority inquiries related to CMC filings.
CrossFunctional Team Leadership:
Collaborate closely with Reg CMC and Technical Development to ensure regulatory CMC deliverables are aligned with product development and submission timelines.
Facilitate effective communication across functional teams to ensure consistency in regulatory submissions and approvals.
Project and Risk Management:
Oversee the planning tracking and of CMC regulatory project timelines identifying and mitigating potential risks that may impact project deliverables.
Manage efforts to streamline regulatory CMC processes and ensure effective coordination between teams and external partners.
Coordinate the timely resolution of CMC regulatory issues including the preparation of risk assessments and contingency plans.
Regulatory Intelligence & Training:
Maintain uptodate knowledge of regulatory guidelines CMCrelated regulations and health authority requirements globally.
Provide training and development opportunities for junior regulatory staff on CMC regulatory submission matters and best practices.
Heres What Youll Bring to the Table:
Education:
Bachelors degree in life sciences chemistry pharmacy biochemistry or a related field;
Additional certification in regulatory affairs (e.g. RAC Regulatory Affairs Certification) is a plus.
Experience:
Minimum of 8 years of experience in Regulatory Affairs/ or Project Management with a focus on CMC and at least 5 years in a project management role.
Experience with regulatory submissions for biologics biosimilars or small molecules (IND NDA MAA BLA variations etc. is essential.
Strong understanding of CMCrelated regulatory requirements across major global markets (FDA EMA ICH etc..
Previous experience in managing processes for submissions within crossfunctional teams and leading complex projects with global scope.
Skills & Competencies:
Strong submission leadership skills with experience managing crossfunctional teams in a regulatory setting.
Excellent project management skills with a proven ability to deliver projects on time within scope and within budget.
Indepth knowledge of CMC regulations good manufacturing practices (GMP) and quality systems.
Ability to navigate and resolve complex regulatory challenges particularly related to CMC issues.
Strong written and verbal communication skills with the ability to effectively present complex regulatory information to internal and external stakeholders.
Detailoriented with strong organizational and multitasking capabilities.
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:
Exec
Employment Type
Full-Time
