VP, Regulatory Affairs

2 weeks ago

Watertown, United States Vigil Neuroscience Full time

Vigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to rapidly deliver precision-based therapies to improve the lives of patients and their families.


The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department. The Vice President represents Vigil in key stakeholder and strategy meetings on all regulatory matters related the company’s development assets, including meetings with executive leadership, meetings with FDA and other regulators, and working with Vigil’s development partners. This role leads the strategy, preparation, review, and submission of documents to the FDA and other global regulatory authorities to support product marketing authorization and lifecycle management. This role combines scientific, regulatory, and business knowledge to assure that Vigil’s products are developed within GxP compliance while meeting Vigil’s strategic goals.


Key Responsibilities:


Regulatory Affairs


Represents regulatory group with internal and external partners.


  • Acts as the company’s regulatory agent and be the company’s main point of contact with the FDA, EMA and other global regulatory agencies.
  • Directs 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.
  • Provides 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; Compile and author documents for submission to regulatory agencies, including premarket notification submissions and pre-market approval applications.
  • Provides leadership in the design and execution of strategies for complex regulatory submissions in close collaboration with other company functions.
  • Represents Vigil before regulatory authorities.
  • Interacts and collaborates with regulatory agency personnel in regard to submission and subsequent approvals and any proposed changes to regulations.
  • Provides technical regulatory input to business development and collaboration opportunities.


Stays informed of global regulatory requirements.


  • Interprets regulatory requirements for all company filings.
  • Interprets changes in regulatory landscape and communicate impact to senior leadership.
  • Keeps management informed of regulatory status of products and significant regulatory issues.
  • Builds partnerships with key regulatory stakeholders.


Quality


Manages all GxP quality activities.


  • Builds the company’s quality system; formulates the company’s GMP, GLP and GCP compliance strategies and provide advice and support for all clinical development programs.
  • 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.
  • Oversees 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.


Assess all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement risk mitigation measures.


  • Develops and implements standards, policies and procedures for GMP, GLP and GCP compliance.
  • Partners with CMC, Clinical Development, Clinical Operations and Pharmacology to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance.
  • Participates 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.


Operations


As the company grows, build a strong regulatory affairs and quality team to meet the needs of the clinical development programs.


  • Manage regulatory and quality vendors.
  • Develop and mentor regulatory and quality staff/personnel.


Candidate Profile:


  • Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry.
  • A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines.
  • Ability to speak and interact with a diverse group of individuals on technical and business topics.
  • Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena, including but not limited to the US.
  • Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.
  • Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively, both internally and externally.
  • Proven ability to lead and manage complex global projects to successful completion.
  • Flexibility/agility to respond to Vigil’s evolving business needs.
  • Strong ability to influence and gain credibility with both internal and external key stakeholders.
  • Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
  • Ability to build collaborative relationships both internally and externally.
  • Ability to inspire, motivate and develop regulatory and quality teams.
  • Ability to prioritize and handle multiple projects simultaneously.
  • Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff.
  • Experience in rare diseases or accelerated approvals is not required but would be a plus.


Principals only, no Recruiters.


#LI-DNI

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