Senior Manager, Regulatory CMC Lead job opportunity at Biogen Inc..

Home Jobs In United States Of America Tag: Regulatory CMC Lead Senior Manager, Regulatory CMC Lead position at Biogen Inc.


DateMore Than 30 Days Ago bot
Biogen Inc. Senior Manager, Regulatory CMC Lead
Experience: 7-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Regulatory CMC Lead

Copy Link Report
degreeAssociate
loacation San Francisco, CA, United States Of America
loacation San Francisco,..........United States Of America

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 activities. In 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 You’ll 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.   Job Level: Management Additional Information The base compensation range for this role is: $138,000.00-$185,000.00 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 $10,000 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 on   to 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.

Other Ai Matches

Director, Data Science & AI Applicants are expected to have a solid experience in handling Data Science & AI related tasks
Senior Process Engineer- Oral Solid Dose and Finished Goods Applicants are expected to have a solid experience in handling Job related tasks
Category Manager Applicants are expected to have a solid experience in handling Job related tasks
Intern, Manufacturing Engineering, Biologics Applicants are expected to have a solid experience in handling Manufacturing Engineering, Biologics related tasks
Sr. Manager, Global Regulatory Affairs- West Coast Hub Applicants are expected to have a solid experience in handling Global Regulatory Affairs- West Coast Hub related tasks
Head of Research Project and Portfolio Management Applicants are expected to have a solid experience in handling Job related tasks
Market Access Lead Applicants are expected to have a solid experience in handling Job related tasks
Commercial / Sales Trainees (w/m/d) für den Einstieg in die Pharmawelt Applicants are expected to have a solid experience in handling Job related tasks
Co-op, Global Trade Compliance Applicants are expected to have a solid experience in handling Global Trade Compliance related tasks
Sr Manager, Rare Disease Customer Engagement Excellence (f/m/d) Applicants are expected to have a solid experience in handling Rare Disease Customer Engagement Excellence (f/m/d) related tasks
remote-jobserver Remote
Clinical Development Lead, Rare Autoimmune Nephrology Programs Applicants are expected to have a solid experience in handling Rare Autoimmune Nephrology Programs related tasks
Head of Value & Market Access GCC Applicants are expected to have a solid experience in handling Job related tasks
Associate Director, Payer Channel Marketing - Nephrology Applicants are expected to have a solid experience in handling Payer Channel Marketing - Nephrology related tasks
Associate Medical Director, Scientific & Value Communications - Nephrology (US Medical Affairs) Applicants are expected to have a solid experience in handling Scientific & Value Communications - Nephrology (US Medical Affairs) related tasks
Head of Portfolio and Project Management, Biogen WCH Applicants are expected to have a solid experience in handling Biogen WCH related tasks
Senior Manager, Global Insights, Nephrology Applicants are expected to have a solid experience in handling Global Insights, Nephrology related tasks
Intern, Global Clinical Supply Chain Applicants are expected to have a solid experience in handling Global Clinical Supply Chain related tasks
Pipeline Medical Science Liaison (MSL) – Nephrology (Fixed Term, 12 months) Applicants are expected to have a solid experience in handling 12 months) related tasks
Senior Category Manager, Direct Materials Applicants are expected to have a solid experience in handling Direct Materials related tasks
remote-jobserver Remote
Director, Global Scientific Society and Medical Community Relations Lead Applicants are expected to have a solid experience in handling Global Scientific Society and Medical Community Relations Lead related tasks
Key Account Manager, Rare Diseases FA (f/m/d) - area Essen, Wiesbaden, Kaiserslautern, Saarbücken, Aachen, Düsseldorf Applicants are expected to have a solid experience in handling Rare Diseases FA (f/m/d) - area Essen, Wiesbaden, Kaiserslautern, Saarbücken, Aachen, Düsseldorf related tasks
Sr Manager Public Policy & Government Affairs (f/m/d) Applicants are expected to have a solid experience in handling Job related tasks
Co-op, Biologic Drug Product Formulation and Stability Assessment Applicants are expected to have a solid experience in handling Biologic Drug Product Formulation and Stability Assessment related tasks