Associate Director, CMC Regulatory Affairs
Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.
At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market.
Your next role as a Miracle Maker
TriLink Biotechnologies, A Maravai LifeSciences company, is seeking a #MiracleMaker to join our Quality team as an Associate Director, CMC Regulatory Affairs. In this role you will be a strategic partner and provide operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) across our product pipeline. You will develop CMC strategies for TriLink products used in the manufacturing of advanced therapies, including cell and gene therapy products. You will collaborate cross functionally with internal teams and clients to ensure compliance with regulatory requirements.
The ideal candidate has deep expertise in CMC regulatory requirements spanning from early-phase clinical trials through commercialization, along with experience working global regulatory agencies (FDA, EMA, MHRA, Health Canada, etc.). Come join our organization for the opportunity to contribute value through your expertise as a miracle maker!
How you will make an impact:
- Develop and implement CMC regulatory strategies for TriLink products across all phases of development.
- Provide guidance to internal teams and clients on applicable FDA/EMA/ICH/Global regulations.
- Provide expertise in translating regulatory requirements into practical, workable plans and procedures to support products and services.
- Review and approve customer contracts (e.g. Quality Agreements, Master Service Agreements, Project Orders, etc.) that meet quality/regulatory requirements, internal capabilities, and customer needs.
- Identify and communicate regulatory risks to management and help identify mitigation strategies.
- Author, review, and provide feedback and/or strategic input on Module 3 section of INDs, CTAs, BLAs, NDAs, MAAs, and other regulatory filings in a timely manner.
- Lead internal teams for developing documentation to support client CMC and other regulatory submission requests, including deficiency letters, and information requests.
- Provide regulatory guidance on CMC changes, including comparability assessments, specification updates, and process modifications.
- Develop and maintain Site Master Files and Drug Master Files (Type II).
- Work with marketing, product management, commercial, legal, quality, etc. to provide regulatory review of promotional marketing materials, labeling, website, presentations, etc.
- Lead and/or support all aspects of any government inspection or interactions.
- Provide regulatory leadership for tech transfers, manufacturing process validations, and comparability studies
- Maintain up-to-date knowledge of domestic and international regulatory requirements and best practices and communicate knowledge of new regulations to project teams.
- Establish functional processes, guidelines, and SOP’s.
- Independently research and interpret regulations and provide regulatory guidance to cross-functional stakeholders; monitor clinical industry and regulatory trends and be able to apply learnings and provide guidance related to such trends.
- Assure compliance with all in-house or external specifications to standards.
- Manage subordinate employees, including training, employee development, and performance management.
The skills and experience that you will bring:
- Bachelor's degree in a scientific discipline or equivalent.
- Regulatory professional with a minimum of 8 years relevant experience.
- Working knowledge of applicable FDA and foreign regulations and guidelines (e.g. ICH Q7; 21 CFR 210, 211; 21 CFR 600, 610; etc. ).
- Experience with pharmaceutical and clinical development of critical raw materials, drug substance, and/or drug product. Preferred experience in advance therapies.
- Experience as a core team member in providing regulatory guidance and successful regulatory strategies.
- Demonstrated experience in the preparation and submission of regulatory documentation (e.g. CMC, INDs, NDAs, BLAs, or MAAs).
- Strong and effective verbal and written communication skills.
- Strong interpersonal, teamwork and customer interfacing skills.
- Prior direct interactions with regulatory authorities
The anticipated salary range for this position is $156,000 - $172,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.
#LI-Hybrid
The benefits of being a #MiracleMaker:
- You have the potential to change, improve, and save lives around the world.
- You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
- We offer comprehensive medical plans and HSA/FSA options.
- Fertility & family planning assistance.
- A variety of additional optional benefits and insurance options, including pet insurance.
- Retirement contributions.
- Holidays & Paid Time Off.
Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/
To view more opportunities to become a #MiracleMaker, visit our career site at https://www.maravai.com/careers/
Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
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