Our client is an innovative biopharmaceutical leader at the forefront of clinical development, driven to reshape and elevate treatment options for those with endocrine disorders. They have retained us to assist in their search for a Senior Vice President of Regulatory and Quality.

Major tasks and responsibilities include:

• Collaborate effectively with internal teams and external partners to design and implement global registration strategies, encompassing initial regulatory efforts for pipeline programs.
• Oversee cross-functional teams and work closely with departments such as Clinical Development, CMC, and R&D to align regulatory and quality initiatives with the company’s strategic business goals.
• Build and mentor a high-performing regulatory and quality team, fostering a culture of continuous improvement and excellence.
• Facilitate problem-solving and drive decision-making within project teams.
• Respond to requests for additional data, organize and manage meetings, and prepare internal teams for regulatory interactions.
• Monitor regulatory publications to stay informed of new or changing regulatory developments and their potential strategic impact.
• Develop and implement regulatory strategies to support product development, commercialization, and lifecycle management, including the preparation and submission of regulatory documents to global health authorities.
• Prepare and submit high-quality sections of briefing documents, INDs, CTAs, and original marketing applications (BLAs/MAAs) in close collaboration with Nonclinical, CMC, Quality, and Clinical teams, as well as external consultants and collaborators as needed.
• Implement clinical/regulatory strategies in collaboration with other functional leaders in the organization.
• Responsible for the management and leadership of Regulatory Affairs, including Regulatory Strategy, Regulatory CMC, Regulatory Operations, Advertising and Promotion, and Labeling.
• Manage the regulatory strategy on a continuing basis, effectively communicating deliverables to the project team and proactively driving teams and external partners to meet designated timelines.
• Communicate the regulatory strategy, risks, mitigations, and overall plans effectively to project teams and the Executive Leadership team as required.
• Establish and maintain excellent relationships with U.S. and global regulatory agencies.
• Negotiate with regulatory authorities regarding company submissions.
• Continue to build, scale, and retain the Quality organization while driving a culture committed to quality and continuous improvement throughout the company.
• Build and develop successful teams accountable for the execution and administration of the GxP Quality Unit to support Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Pharmacovigilance (GPV) quality compliance in accordance with FDA (Food and Drug Administration), ICH, and EMA regulations, guidelines, and industry standards.
• Develop and implement the overall quality strategy and vision for laboratory operations.
• Continue to build and optimize the company’s Quality Management System (QMS) to ensure it is effectively designed, implemented, and maintained to support company growth and program advancement.
• Collaborate cross-functionally, developing strong relationships with partners both internally and externally.
• Identify critical compliance and/or business issues related to cGxP CDMOs, CROs (Contract Research Organizations), contract test laboratories, manufacturers of critical starting materials, and internal document and data management practices. Create and execute tactical plans to address gaps.
• Drive major/critical deviation investigations to ensure minimal risk to product and study quality, efficacy, and safety. Collaborate with relevant functions to define root cause(s) and develop effective CAPAs.
• Ensure the facility, processes, and systems (including SOPs and associated training) are maintained in an audit- and inspection-ready state. Ensure effective CAPAs are implemented to mitigate risks, and track and document CAPA effectiveness.
• Direct the company’s quality training program and partner with functional leadership to define curricula by function, ensuring timely and documented completion of employee training.

 
We seek candidates with the following qualifications:

• Bachelor’s degree in biological sciences or a related field is required; an advanced degree (MS, PhD, or PharmD) is strongly preferred.
• Minimum of 20 years of progressively responsible regulatory and quality experience in the biopharma industry, with a preference for expertise in peptides and a proven track record spanning all clinical phases through commercialization.
• Leadership experience in a small or virtual biopharma setting is highly preferred.
• Proven track record of fostering collegial relationships with regulatory agencies.
• Strong knowledge and ability to apply GMP, GCP, and GLP standards in conformance with US, EU, and ROW regulations.
• Demonstrated success working in a collaborative team environment where results are achieved through influence and incorporating multiple perspectives.
• A strategic and enterprise thinker who can break down barriers, drive sound decisions, and make a meaningful impact.
• Experience in building and administering platform-based quality systems while developing teams for both current and future needs through focused hiring, coaching, and development.
• A resilient, inspiring, and visionary Regulatory and Quality leader capable of fostering a strong culture across the organization.
• Ability to effectively negotiate, foster collaboration among individuals, and lead cross-functional and cross-company quality initiatives.
• Travel is expected to be 25%.

 
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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