Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of both marketed products and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
The Director Regulatory Affairs Global Regulatory Lead, is responsible for developing and implementing global strategies to drive development of multiple oncology early development assets, contributing to the advancement of leading-edge cancer research in a nimble, biotech–like environment within a large, well established pharmaceutical company. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables, expands TA knowledge, proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, demonstrates understanding of drug development and leadership behaviors consistent with level, develops and implements acceleration strategies, and ensures alignment of global regulatory strategies with senior management. This position is based at AbbVie in the South San Francisco, CA location. May have direct reports.
- Serve as the global regulatory lead on project teams and key sub-teams. Accountable for ensuring that global regulatory strategies are aligned with senior management and corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products. Advise management of the effect of current or proposed laws, regulations, guidelines and standards, etc. Influence the development of regulations and guidance.
- Develop and implement competitive and effective global regulatory strategies for several products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies. Follow company policies and procedures for regulatory record keeping; may develop and implement policies and procedures within the RA department and, if applicable, ensures direct reports follow requirements.
- Provide informed regulatory opinion, advice and guidance based on experience and expertise to project teams on the interpretation and application of relevant regulatory requirements and review processes, and proactively inform project teams and management of issues, risks, and mitigations.
- Collaborate with AbbVie regional and country regulatory affiliates and CROs to support global clinical development activities.
- Serve as primary Health Authority contact for assigned projects as applicable and foster positive and effective working relationships between project team members and Health Authority reviewers. Prepare teams for and lead Health Authority meetings.
- Participate in and manage the creation, review, assembly, and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate. Ensure consistency/completeness/adherence to standards for all regulatory submissions.
- Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation.
- Support non-program specific projects as assigned, such as leading/participating in department initiatives, business development assessments, clinical assessments and department training, etc. Advance the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects. Based on experience and scientific strengths, expands TA knowledge; provide coaching and mentoring for GRPT members. May have direct report(s), and contribute to the performance management for other RA team members.
- Required Education:Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
- Preferred Education:Relevant advanced degree is preferred. Certification a plus.
- Required Experience:7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US&C region. Proven 3-5 years in a leadership role with strong management skills.Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
- Strong communication and proactive negotiation skills. Experience contributing to enterprise management of a portfolio of products. Experience interfacing with government regulatory agencies. Experience developing and implementing successful global regulatory strategies.
- Preferred Experience:10 years’ experience in pharmaceutical regulatory activities; preferably with experience as lead regulatory product strategist in two or more major regions such as EU or Japan.Strong clinical foundation preferred with business acumen. Note: Higher education may compensate for years of experience.
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced