What are the responsibilities and job description for the Director, Global Regulatory Affairs Strategy position at ABBVIE?
- Leads a team of regulatory professionals who develop strategy for development and marketed products. Ensures inclusion of strategic messaging in the content of global regulatory dossiers. Seeks expert advice and technical support when necessary from Director and TAH level personnel.
- Leads preparation and maintenance of global, US and Canadian regulatory product strategies. Under guidance of supervisor, leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
- May participate in regulatory and Company initiatives and contributes to the performance management for other Regulatory Affairs team members.
- Influences the development of regulations and guidance. Analyzes legislation, regulation and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
- Under supervision, 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.
- Under direction of supervisor, provides executive management with meaningful regulatory measurements and regulatory opinion.
- Works with GRPT to develop, communicate goals that are in alignment with the business goals. Under supervision of a Director level GRL 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.
- 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:5 years of regulatory experience. Some portion may include relevant exposure 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, and with multiple stakeholders. Experience interfacing with government regulatory agencies. Experience working with Health Authority
- Strong communication and proactive negotiation skills. Business acumen and able to work under pressure
- Preferred Experience:7 years’ experience in pharmaceutical regulatory activities; preferably in at least 2 regions/major countries.Experience developing and implementing successful global regulatory strategies.Strong clinical foundation preferred.Note: Higher education may compensate for years of experience
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
-
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
-
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
-
This job is eligible to participate in our short-term incentive programs.
-
This job is eligible to participate in our long-term incentive programs.
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 and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
Salary : $145,000 - $275,500