Director, Global Regulatory Lead

The Director, Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Manages projects and necessary documentation of regulatory strategies.

• 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 5 years in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment with multiple stakeholders and influencing cross-functional teams. Experience interfacing with major government regulatory
• Required Experience cont'd:
  Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.
• Preferred Experience:
  10 years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen.
• Note: Higher education may compensate for years of experience.

Applicable to California Applicants Only

· The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.

This range may be modified in the future.

· The salary range is (minimum: $ 168,000 to maximum: $ 328,000)

· This job is eligible to participate in our short-term incentive program

· This job is eligible to participate in our long-term incentive programs

· We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

• • Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

• Job Field: Regulatory Affairs
• Job Type: Experienced
• Organization: Research & Development
• Schedule: Full-time
• Travel: Yes, 5 % of the Time