DEPARTMENT: Regulatory Affairs
LOCATION: Durham, NC, Fully Remote
JOB SUMMARY:We are seeking a Senior Director, Head of Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role will lead strategy, compliance, and submissions for complex manufacturing processes and report to the Chief Regulatory Officer.
ESSENTIAL FUNCTIONS:- Generate, review, and approve regulatory submissions associated with CMC
- Lead and manage the RA CMC team; mentor RA CMC team members
- Develop current and long-term strategies and objectives for regulatory CMC, that align with overall company strategy and seek approval from executive leadership and implement strategic plans in collaboration with Manufacturing and Process Development
- Participate with executive leadership to proactively identify potential regulatory CMC risks to the organization, make adequate recommendations for mitigating risks and collaborate with other senior leaders in Manufacturing, MSAT and Process Development to implement selected and agreed upon strategies across all areas of the organization
- Assure sustainable, harmonized regulatory compliance for Humacyte manufacturing sites and contracted manufacturing operations (as applicable) through expert level insight, evaluation and support
- Identifies and implement regulatory requirements for Design and Development, Technology Transfer, and Manufacturing/Bioprocessing
- Collaborate with Quality on Regulatory communications associated with U.S. and international regulatory inspections, including Pre-Approval Inspections
- Serve as the main point of contact with Development, MSAT, Manufacturing, Quality Assurance, Validation, and Quality Control regarding CMC regulatory compliance and reporting requirements
- Represents Humacyte for CMC discussions at meetings with regulatory authorities, including U.S. FDA and other competent authorities
- Prepares, reviews, and approves correspondences, submissions, protocols, and reports in support of regulatory filings (IND, IMPD, BLA, MAA, etc.)
- Maintain consistent application of ICH Q9 Quality Risk Management principles in product development and lifecycle operations
- Manage and maintain policies, processes, and procedures associated with Humacyte's Tissue Processing operations (internal or contracted) per 21 CFR Part 1271 and international regulations related to Human Cells, Tissues, and Tissue-Based Products
- Demonstrate and apply thorough understanding of U.S. FDA, EU, and Rest of World (ROW) regulations with respect to aseptic processing, biologics manufacturing, market authorization, and human cell and tissue-based products, including but not limited to: 21 CFR Parts 11, 210, 211, 600, 820, 1271; and relevant European Directives (EudraLex Volume 4, 2001/83/EC, 2004/23/EC)
EXPERIENCE & QUALIFICATIONS:- Minimum 8 years in a director-level and above role in Regulatory CMC or related function in a Biotechnology-related field
- Demonstrated experience in collaborating with the Quality department to prepare for and execute regulatory inspections including preparation, representation, and closing out of observations
- Proven record of CMC writing, reviewing, and approving regulatory submissions on topics of biological and cell therapy CMC processes and compliance, including pre-clinical stage, clinical stage, commercial-stage products and product candidates
- Demonstrated experience in developing, communicating, and implementing regulatory and compliance strategies to assure success in design, development, and commercialization processes for biologic products and medical devices
- Demonstrated knowledge of and expertise in product life cycle management, consistent with ICH and other international consensus guidelines
- Demonstrated success with planning, executing, and closing international regulatory inspections, with a focus on European regulatory submissions
- Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
- Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
- Excellent organizational and time management skills with a keen ability to set own priorities in a timely manner.
- High degree of flexibility and adaptability.
- Self-motivated and critical thinker with outstanding interpersonal and business communication skills.
- Represents the organization in a positive and highly professional manner.
Minimum education required for Senior Director, CMC Regulatory Affairs
:- Minimum BS degree in a biologics-related discipline, with education focus in biology, chemistry, biochemistry, microbiology, cell biology, or biotechnology required
COMPENSATION & BENEFITS HIGHLIGHTS:- Competitive base compensation and bonus
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term/Short Term Disability
- Company Paid Life Insurance
- Assortment of other voluntary benefits, including pet insurance; hospital indemnity; accident & critical illness plans; voluntary life insurance; legal protection plans and more
- 23 Days Paid Time Off (PTO) to start
- 10 Company Designated Holidays + 2 Floating Holidays
- Paid Parental Leave Policies
** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **
