Biibhr
Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP)
Cambridge, MA
Sponsorship not specified$241k-$332kDetected 1 day ago
ComplianceNegotiationLeadershipCommunicationCollaborationProblem Solving
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Lottery odds (Level IV)94
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About the role
- Your role encompasses global, regional, and local accountability for all therapeutic areas relevant to these modalities.
- By leading multiple projects in a fast-paced environment, you will play a crucial role in delivering on our product portfolio, providing strategic oversight to ensure timely approvals and lifecycle progression.
- Your leadership will be pivotal in fostering collaboration across the company, aligning regulatory strategies with manufacturing readiness and supply continuity.
Responsibilities
- Lead the CMC regulatory team in the development and execution of global CMC regulatory strategies for biologics and ATMPs.
- Assess regulatory risks and develop mitigation approaches to support timely product approvals.
Requirements
- You are a visionary leader with a deep understanding of regulatory sciences, skilled at navigating the complexities of biologics and ATMPs.
- Required Skills:
Skills
- Advanced Degree or Ph.D. in Life Sciences, Pharmacy, Medicines, or related discipline.
- Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry.
- Significant leadership experience in Regulatory Sciences.
- Proven track record of successful global regulatory submissions and approvals for biologics and/or ATMPs.
- Significant understanding of international regulations and policy-setting processes of major regulatory agencies.
- Active engagement in major industry associations, conferences and forums.
- Strong collaboration and negotiation skills with cross-functional teams.
- Job Level: Management
- Additional Information
- The base compensation range for this role is: $241,000.00-$332,000.00
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- You will manage resources, set a vision, and ensure alignment between regulatory strategy, technical development, and manufacturing execution.
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Paid Maternity and Parental Leave benefit
- Guide global interactions with Health Authorities for CMC topics, preparing briefing materials and responses to agency questions.
- Short- and Long-Term Disability insurance
- 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.
Company info
- We are a global team with a commitment to excellence, and a pioneering spirit.
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- 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.
This listing is sourced directly from Biibhr's careers page and normalized into a canonical job model.