Associate Director/Director Regulatory Affairs CMC

We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

The primary function of this position is to perform CMC Regulatory activities required for approval and maintenance of marketing authorizations at Humacyte. These activities include representing Regulatory Affairs in critical CMC activities including, but not limited to: Management of Change and Change Control Review Board; Annual Product Quality Reporting; developing CMC Regulatory Standard Operating Procedures and Work Instructions; preparation and submission of CMC changes to FDA, EMA, and other international health authorities; partnering with Quality for preparation and management of regulatory inspections; and managing post-inspection regulatory response strategies and submission activities.

This position reports to the Global Head, CMC Regulatory

Remote Work Designation: Partially Remote

Major Accountabilities:

• Responsible for project management for CMC regulatory activities in the US, EU, Japan, and other countries/regions
• Responsible for preparation of Module 3 of regulatory submissions in US, EU, and other international health authorities
• Has strong understanding of general public company operations including establishing and executing to objectives as they relate to departmental and/or team cascading goals, budget management, and optimal outcomes
• Provides technical writing support for IND, BLA, and MAA submissions
• Collaborates with subject matter experts within the organization on the generation of reports and quality sections of submissions
• Participate in and provide regulatory guidance to scientific discussions associated with pipeline development and associated regulatory submissions
• Provide regulatory expertise and guidance, interpret health authority or ICH guidance in quality domain to new indications for current products and new product development
• Develop, implement, and maintain domain knowledge in global regulatory science, policy, and current trends in biologics regulations focus on Quality
• May prepare quality sections of briefing packages for regulatory meetings
• Other duties as assigned

Special Competencies:

• Thorough understanding of the electronic Common Technical Document, Investigational New Drug, Biologics License Application, Investigational Medicinal Product Dossier, and associated regulatory authorization documents and processes
• Generating and editing elements of Module 3 of the electronic Common Technical Document
• Representing CMC Regulatory Affairs on all pre- and post-approval change management activities
• Managing pre- and post-approval reporting to international health authorities (Annual Product Quality Report and all change-related submissions)
• Supporting CMC focused meetings with FDA and meetings with other international health authorities
• Supporting cGMP regulatory inspections and other third-party audits as required

General Competencies:

• Able to communicate effectively in English, both verbally and in writing

• Possess a positive roll-up-the-sleeves attitude and optimistic outlook

• Represents the organization in a positive and professional manner

• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others

• Excellent organizational and time management skills with ability to set own priorities in a timely manner

• High degree of flexibility and adaptability

• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

• Must be able to work as needed to meet tight deadlines and at peak periods

• Self-motivated and organized critical thinker with solid interpersonal and business communication skills

• Demonstrated ability to work in a cross functional team

• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements

• Always observe safety precautions and regulations in all areas where duties are performed

• Responsible for reporting all safety hazards and potential unsafe working conditions

• Reports to work on time and as scheduled

QUALIFICATIONS:

• Bachelor’s degree in Science or Engineer is required. Higher degree is highly desirable.
• 5-7 years of regulatory affairs experience required, and 4-5 of them focused on RA CMC
• At least 3 years of experience as the responsible person for eCTD Module 3 in IND/NDA/BLA/MAA submissions required
• Proficient in Microsoft Project and project management platforms required
• Strong scientific background and associated technical/scientific writing skills required
• Experience with biologics and/or cell, tissue therapy manufacturing operations required
• Experience with leading meetings with FDA/CBER preferred
• Experience with hosting or assisting FDA and other health authority cGMP inspections preferred
• In-depth knowledge of GCP, GMP, GLP, and GTP regulations as well as FDA and other country regulations preferred
• Prior experience in Quality Management preferred

Perks:

• 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
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**