Senior Manager, Regulatory CMC Lead
Share
Job Location:
San Francisco, CA - USA
Monthly Salary:
$ 138000 - 185000
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
About This Role:
As a Senior Manager Regulatory CMC Lead you will provide regulatory CMC expertise to support assigned projects and products contribute to global CMC regulatory strategy and where appropriate lead regulatory submissions and related strategic activities. You will be part of a dynamic team collaborating closely with the CMC Global Regulatory Lead and key stakeholders to compile and prepare submissions/documentation for biologics projects.
Your role will involve managing routine and non-routine regional Health Authority interactions serving as the primary global contact for regulatory CMC late-stage development programs you will be the contact for assigned regions ensuring seamless communication and execution of the regulatory CMC strategy. This position is vital to the success of our business as it ensures compliance and facilitates the advancement of our projects within the regulatory framework.
This is a hybrid role based in our office in San Francisco CA (Biogen West Coast Hub).
What Youll Do:
Provide regional strategic and operational regulatory CMC expertise and support in cross-functional teams.
Prepare and deliver CMC regulatory operational plans and submissions in assigned regions and support the preparation and delivery of regulatory submissions (in the clinical initial marketing or post-approval phase).
Lead the review and ensure accurate submissions to Health Authorities.
Write and review regional and global CMC submission documents and responses.
Manage CMC aspects of routine and non-routine Health Authority interactions.
Monitor regulatory CMC environment changes to support CMC global lead and teams.
Provide input into regulatory CMC risk assessments and mitigation plans.
Coordinate and complete regulatory assessments of CMC changes.
Assume responsibilities from the Global Regulatory Lead as delegated.
Lead or assist in Reg CMC initiatives and development of standards and SOPs.
Maintain appropriate records in the designated system for submissions.
Who You Are:
You are an experienced leader with a deep understanding of regulatory CMC processes and a proven ability to work across functions and cultures. Your strong communication skills and strategic thinking enable you to lead projects and navigate complex regulatory landscapes. You are collaborative adaptable and thrive in a global setting effectively building relationships and managing responsibilities across time zones. Your enthusiasm for teamwork and inclusive leadership style make you a valuable asset to any project team.
Required Skills:
BS Degree in Life Sciences Engineering Biotechnology or relevant Pharmaceutical Science
7 years of relevant experience in the pharmaceutical industry or regulatory authority CMC review capacity with a minimum of 3 years of experience in Regulatory CMC.
Proven experience authoring and contributing to CMC submission documents for development and marketed products.
Broad registration experience in the pharmaceutical industry or a regulatory authority.
Direct communication and negotiation experience with regulatory agencies on CMC matters.
Knowledge of GMP requirements and standard systems.
Demonstrated competence in leading cross-functional teams.
Ability to work independently and within project teams.
Demonstrated inclusive leadership and emotional intelligence.
Strategic thinking and risk assessment skills.
Proven project management abilities across global locations and time zones.
Preferred Skills:
Graduate degree
Recognized experience in project and timeline management.
Experience with clinical development and associated regulatory CMC submissions.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
Senior Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
