Vice President of Regulatory & Quality

This clinical-stage biotech company is developing innovative treatments for multiple neurodegenerative diseases. They are seeking a Vice President (or SVP) of Regulatory & Quality to build and lead both functions, and serve as the primary contact with FDA. Reporting into the CMO, you will provide crucial input on all regulatory matters related to the company’s development assets and lead interactions with Health Authorities. This company offers a patient-focused culture, innovative science, and excellent employee benefits. With two programs in clinical trials, now is an exciting time to join this growing organization!

Responsibilities:

1. Build and lead the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the company.
2. Serve as the company’s regulatory agent and be the company’s main point of contact with the FDA, EMA and other global regulatory agencies.
3. Direct the strategy (time, tone, and content) of interactions with the respective regulatory health authorities, including the request, preparation and execution of meetings with regulatory authorities for product specific issue and policy related issues.
4. Provide regulatory guidance for the planning and compilation of critical documentation related to U.S. and worldwide submissions. Manage and prepare regulatory documents and submissions in accordance with business strategies.
5. Interact and collaborate with regulatory agency personnel regarding submission and subsequent approvals and any proposed changes to regulations.
6. Provide technical regulatory input to business development and collaboration opportunities.
7. Stay informed of global regulatory requirements and interprets regulatory requirements for all company filings. Communicate impact of changes to senior leadership.
8. Hire and manage direct reports and consultants, as well as other duties as appropriate.
9. Build the company’s quality system; formulate the company’s GMP, GLP and GCP compliance strategies and provide advice and support for all clinical development programs.
10. In close partnership with the Head of QA, as needed, oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
11. In close partnership with the Head of QA, as needed, oversee the QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports and essential clinical study documents.
12. In cross-functional partnership, assess all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement risk mitigation measures.
13. Develop and implement standards, policies and procedures for GMP, GLP and GCP compliance as needed in addition to what is in place.
14. Partner with CMC, Clinical Development, Clinical Operations and Pharmacology to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance.
15. Participate in the evaluation and selection of contract manufacturing sites, analytical testing sites, clinical storage and distribution depots, CROs and other service providers used to support the clinical development programs.
16. Build a strong Regulatory Affairs and Quality team to meet the needs of the clinical development programs.
17. Develop and mentor regulatory and quality staff/personnel.
18. Forecast budgets and develop department best practices and SOPs.

Qualifications:

1. Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred.
2. A minimum of 15 years of Regulatory Affairs experience in the biopharmaceutical industry.
3. Experience in Rare Diseases programs required. CNS/Neurology experience a plus.
4. Significant demonstration of creative strategy and boundary pushing with health authorities.
5. A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines.
6. A track record of successful interaction with FDA and other regulatory agencies.
7. Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.
8. Ability to review, understand and explain the regulations and guidance documents to guide project teams.
9. Experience filing successful marketing applications (NDA, BLA or MAA). Prior successful drug approvals a plus.
10. Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena, including but not limited to the US.
11. Experience in Quality Assurance and the oversight of QA function desired but not required.

Leadership, Interpersonal and Soft Skills:

1. Previous Regulatory team leadership desired.
2. Strong ability to influence and gain credibility with both internal and external key stakeholders.
3. Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction.
4. Ability to build collaborative relationships both internally and externally.
5. Ability to inspire, motivate and develop regulatory and quality teams.
6. Ability to prioritize and handle multiple projects simultaneously.
7. Ability to speak and interact with a diverse group of individuals on technical and business topics.
8. Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.
9. Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively, both internally and externally.
10. Proven ability to lead and manage complex global projects to successful completion.
11. Must be flexible with ambiguity in a small company environment.

This is a hybrid onsite position in the Boston (2-3 days per week) and our client prefers local candidates in the Boston area.

The budgeted salary range for this position is $330,000 to $350,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

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