VP Regulatory and Quality, Rare Disease 1072685
Job Scope & Purpose:
Our client offers a tremendous culture and stimulating work environment to a biotech-minded Regulatory professional with strong knowledge of Quality. Reporting directly to the CEO, the successful candidate would provide a high level of experience to our client's global clinical, non-clinical, and CMC Regulatory strategies.
Primary Job Responsibilities:
- Provide regulatory guidance throughout the development process
- Oversee Quality
- Prepare clear and effective regulatory submissions on behalf of company leveraging internal and external resources
- Prepare and lead meetings with regulatory bodies to include but not limited to Pre-IND meetings, Type C meetings, EOP II meetings, pre-NDA meetings, and EU Scientific Advice
- Be primary contact with regulatory bodies in US and Internationally, while building and maintaining strong relationships
- Review, analyze and translate regulatory requirements into a workable deliverable for project meetings, senior and executive management decisions.
- Supervise, interact with and/or coordinate with contract regulatory staff and external service providers to ensure adequacy of project support and deliverables.
- Author, review and edit regulatory documents and packages for submissions to national regulatory authorities (NRAs) and/or scientific or executive management meetings
- Build the Regulatory and Quality functions that can support Phase 2/3 clinical trials to product registration
- Serve as lead writer for high priority submissions such as meeting briefing materials (slides/documents) and coordinate with service providers to ensure document publishing
- Conversant with all aspects of the external regulatory and quality assurance environment, including upcoming regulations and regulatory positions, thereby providing the company with the necessary regulatory technical expertise and counsel to ensure success in developing its products. Ensure learnings shared with staff.
- Review and edit, as appropriate, press releases, presentations for external meetings.
Primary Job Requirements:
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements for early and late stage development programs
- Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project
- Solid knowledge of ====Ps and GLPs
- Experience in cGMP a plus
- Direct experience in interfacing with relevant regulatory authorities
- Experience working in a small biotech company environment for 5+ years
- Regulatory experience in rare/ultra-rare diseases
- Demonstrate excellent leadership and communication skills
- Demonstrate strong organizational skills, including the ability to prioritize personal workload
- Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff
- Experience with eCTD, e-publishing systems for preparing regulatory submissions
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or