Vice President, Regulatory Affairs
This clinical-stage pharmaceutical company is developing and commercializing innovative therapies for women's health and prostate cancer. With multiple programs in Phase 3, they are seeking a Regulatory Affairs Vice President, reporting to the SVP of Regulatory and Quality, who can lead development of all non-clinical, clinical, and commercial regulatory strategies including management of IND and NDA submissions, FDA and other regulatory interactions, as well as international submissions. In addition, this role is responsible for building and managing regulatory operations and medical writing teams. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. This company offers an incredible company culture, competitive compensation, equity, and great employee benefits. Now is an exciting time to join this growing organization and to help get new women’s health products approved!
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks for non-clinical, clinical and commercial development plans and activities; Develop regulatory strategic plans in conjunction with project teams.
- Define strategy and required content of scientifically sound, accurate and complete nonclinical and clinical submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc.)
- Interact with and key point of contact for regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
- Oversee the preparation of meeting requests and briefing documents, and plan, execute and lead the coordination and preparation of teams for health authority meetings.
- Oversee compilation, electronic processing and publishing to ensure high quality and timely electronic submissions compliant with regulatory authority requirements.
- Monitor changes in the regulatory environment; Interpret and analyze regulatory legislation, guidance and precedent as well as external developments to provide direction to internal stakeholders, especially on regulatory matters that may affect ongoing development programs.
- Ensure compliance of labeling, promotional and educational materials with governing Health Authorities.
- Support development and presentation of development strategies to governance bodies.
- Provide strategic and operational leadership to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion in accordance with business goals and objectives, regulations, guidelines, and company policy.
- Provide leadership and direction to clinical regulatory, commercial regulatory, medical writing and regulatory operations groups. Manage workload, provide coaching and development, train staff and effectively allocate resources. Lead implementation of organizational infrastructure and effective functional operations to meet corporate objectives and milestones.
- Oversee the maintenance and creation of relevant SOPs, Work Instructions and other necessary guidance.
- Recruit, develop, manage and mentor regulatory professionals and drive a culture of excellence that motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals.
- Advanced degree MD, PharmD, or PhD preferred along 15 years of biopharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs
- Proven experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs)
- Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional).
- Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (eg, changing regulatory environment, new competition, shifting market environment) along with the ability to balance short-term needs with long-term vision.
- Demonstrated leadership excellence, proven ability to motivate and lead people in a complex, changing environment, and the professional maturity to overcome ambiguity and lead others through both, influence and direct authority.
- Positive attitude and team player willing to roll up her/his sleeves as the situation requires to get the right result; ability to combine hands-on attention to detail with the ability to step back and think strategically
- Deals effectively with pressure; remains flexible, proactive, resourceful and efficient, even under adversity; Adept at successfully multi-tasking and prioritizing competing work streams with tight timelines.
- Excellent interpersonal, oral, and written communication skills including presentation skills
- Unwavering integrity and honesty with a quality mindset and a passion for excellence.
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Equal Employment Opportunity