Executive Director, Regulatory Affairs
Posted on Apr 5, 2021 by Pharmacyclics
A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.
First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
- Lead a team of global regulatory professionals for strategy on development and marketed products. Responsible for oversight of complex product development and project management. Accountable for ensuring that corporate goals are met. Manage the content of global regulatory dossiers. Provide oversight and approval for content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy.
- Lead preparation of global regulatory product strategies for assigned products. Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
- Provide executive management with informed regulatory strategies and risk assessment. Provide mentoring, coaching to other regulatory and cross-functional personnel and contributes to their performance management. May have direct reports.
- May initiate, participate or lead RA or cross-functional initiatives. Advise internal personnel on regulatory strategies.
- Work broadly across TAs for assigned products and influences the development of regulations and guidance. Advise management of the effect of current, newly finalized or proposed laws, regulations, guidelines and standards, advisory committee recommendations on assigned products.
- Provide expert assessment on disease state insights, vision and direction to differentiate assets, regulatory intelligence on global regulatory environment and provides recommendation to accelerate and optimize product development. Follow company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department, and if applicable, ensures direct reports follow requirements.
- Proactively inform regulatory management of issues and provides an assessment of impact on the global, US and Canadian programs. Provide informed regulatory opinion based on experience and expertise.
- Work with GRPT to develop, communicate goals that are in alignment with the business goals. Under supervision of a Director or TA Head, communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management. Make decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
- Participate in, take leadership roles in professional associations, industry and trade groups as appropriate for assigned projects. Present to cross-functional teams. Represent Regulatory on governance and review committees at the request of the TA Head.
- Follow budget allocations and keeps supervisor informed on project resourcing. Provide management with insight regarding generalized changes in regulatory work/environment/processes that may affect future resourcing.
- Bachelors degree (pharmacy, biology, chemistry, pharmacology) related life sciences (Required)
- Preferred Education: Relevant graduate degree preferred. Certifications a plus
- 10+ years in Regulatory Affairs. Some portion may include experience related to pharmaceutical regulatory work (eg, other R&D role or specialized training). Requires drug development experience in US region. 10+ years in pharmaceutical, R&D or related industry experience.
- Proven 5+ years in a leadership role with strong management skills, demonstrated executive presence. Experience working in a complex and Matrix environment with multiple stakeholders and on cross-functional teams.
- Experience bringing pharmaceutical products through development review and approval. Broad experience contributing to enterprise management of a portfolio of products. Experience developing and implementing successful global regulatory strategies. Experience interfacing with government regulatory agencies. Strong verbal and written communicator with strong negotiation skills and strategic thinking. Strong business acumen and the ability to work under pressure.
- Preferred Experience: 10+ years' experience in pharmaceutical regulatory activities, preferably with experience as lead regulatory product strategist in at least 2 regions (EU, JAPAC, etc.). Extensive experience interfacing with multiple regional government regulatory agencies preferred.
- Clinical foundation preferred with strong business acumen. Experience in multiple Therapeutic Areas and experience with small molecules and biologics preferred.
In this role, we're looking for a leader who will:
- Act as an Owner
- Be Excellence Focused
- Act as an Influencer