Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
About The Position
The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to support delivery of biologics products, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and cell and gene therapies. The role prepares CMC regulatory strategies to enable first-pass approvals and develops and manages content strategies for regulatory submissions, including INDs/CTAs and amendments, new marketing applications, and supplements or variations. The position builds and maintains relationships across Regulatory Affairs, Operations, and Research & Development. It represents CMC on product development, Global Regulatory Product, and Operations brand teams, providing strategic advice and influencing decisions. The role works on a hybrid schedule of three days in the office and two days remotely, based at the Waltham, Massachusetts and Lake County, Illinois headquarters.
Requirements
- Bachelor’s degree in pharmacy, chemistry, biology, pharmacology, engineering, or a related subject.
- Eight years of pharmaceutical experience.
- Experience developing and implementing successful global regulatory strategies.
- Experience working in a complex, matrixed environment.
- Strong oral and written communication skills.
Nice To Haves
- Relevant advanced degree.
- Certification.
- Ten years of pharmaceutical experience, including five or more years in regulatory affairs or five or more years in Discovery, R&D, or Manufacturing.
Responsibilities
- Prepare CMC regulatory product strategies.
- Prepare and manage regulatory submissions, including new applications, amendments, renewals, annual reports, supplements, and variations, and respond to regulatory information requests.
- Analyze and interpret information that affects regulatory decisions, seeking expert advice and technical support when needed.
- Review and revise regulatory submissions to present data and strategy effectively to regulatory agencies.
- Respond to global regulatory information requests.
- Develop CMC strategies for agency meetings, manage meeting preparation, and oversee the content of pre-meeting submissions.
- Manage products and change control in accordance with regulations and company policies and procedures; analyze and approve manufacturing change requests.
- Represent CMC Regulatory Affairs on assigned product development, Global Regulatory Product, and Operations brand teams, negotiating and influencing team members with management support to maximize the likelihood of first-pass regulatory submission approval.
- Monitor regulatory procedures and changes in the regulatory climate; analyze legislation, regulations, and guidance and provide analysis to the organization.
- Develop, implement, and document Regulatory Affairs policies and procedures, and participate in internal RA CMC initiatives.
- Represent CMC Regulatory Affairs on cross-functional project initiatives to drive company efficiencies.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
