Senior Manager, Regulatory CMC Lead

*
* 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: $-$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…