The Director, Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global, US and Canadian regulatory strategies to secure and maintain market approval in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT), expands TA knowledge, and manages strategic messaging and content of global, US and Canadian regulatory dossiers. Serves as the primary regulatory interface with ADT and supporting teams. 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. Ensures alignment of global regulatory strategies with Sr. management. May have direct reports.
- Leads a team of global regulatory professionals for development and marketed products. Accountable for ensuring that corporate goals are met. Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned products.
- Leads preparation of global, US and Canadian regulatory product strategies for assigned products. Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
- Acts independently under the direction of a GPS TA Head. May participate in or lead initiatives. Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for GRPT members. May have direct report and contributes to the performance management for other RA team members. Influences the development of regulations and guidance. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc.
- Advises internal personnel on regulatory strategies. Follows 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.
- Ensures alignment of global regulatory strategies with Sr. Management. Proactively informs ADT and management of issues, risks and mitigations. Provides assessment of impact on global, US and Canadian programs. Provides informed regulatory opinion based on experience and expertise.
- Works 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.
- Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
- Follows budget allocations and keeps supervisor informed on project resourcing.
- 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.
- Required Experience cont'd: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: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 10 % of the Time
Job Type: Experienced