Senior Associate, Regulatory CMC

HUMACYTE GLOBAL INC•Durham, NC

9h•Remote

About The Position

We are seeking a Senior Associate, Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role will directly support strategy, compliance, and submissions for complex manufacturing processes and report to the Head of Product Quality and Regulatory. Prepares CMC regulatory strategies that enable first pass approvals under management supervision. Develops and manages content strategy for regulatory submissions, including new market applications and supplements/variations under management supervision. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams.

Requirements

Minimum 5 years in the pharmaceutical industry in Regulatory CMC or related function in a Biotechnology-related field.
1-2 years in Regulatory affairs is preferred.
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 BS degree in a biologics-related discipline, with education focus in biology, chemistry, biochemistry, microbiology, cell biology, or biotechnology required

Responsibilities

Prepares, reviews, and approves correspondences, submissions, protocols, and reports in support of regulatory filings (IND, IMPD, BLA, MAA, etc.)
Serve as business owner of electronic system used as regulatory documentation repository and submission database
Owner of Regulatory program and system SOPs. As owner ensure alignment with current practices, guidance, and drive continual improvement and periodic review.
Support the regulatory affairs team in the development of 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
Analyze and interpret information in support of identifying 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 implements 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 a point of contact with Development, MSAT, Manufacturing, Quality Assurance, Validation, and Quality Control regarding CMC regulatory compliance and reporting requirements
Supports products and change control assessments with an understanding of regulations and company policies and procedures under management supervision. Analyzes and approves manufacturing change requests under management supervision.
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)

Benefits

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