The Senior Manager, Regulatory Affairs Business Excellence is responsible for the implementation and development of global regulatory policies and procedures. Represents Regulatory Affairs on process improvement initiatives and shared service model teams. Working with manager, communicates regulatory policies, systems updates, and procedures to teams developing pharmaceutical and medical devices. Ensures successful planning and completion of regulatory activities for entire department. Responsible for knowledge of regulatory requirements and processes with responsibility for working with colleagues on a worldwide basis. Helps maintain compliance of global regulatory document management systems and generates metrics for the department. Responsible for covering multiple development and process improvement projects.
Represents pharmaceutical and device Aesthetic Regulatory Affairs Business Excellence function on cross-functional and shared service teams to ensure consistent alignment on processes across all areas of the R&D organization. Provides input to teams to align on Aesthetic ways of working. Working with manager, responsible for development and communication of global regulatory activities on R&D project teams.
Contributes to process and operational improvement activities. Participate in internal/external collaborative cross-functional teams required for process and operational improvement activities, including the application of change management.
Assist in developing, implementing, and maintaining standardized business processes, work instructions and job aids in support of regulatory requirements for the document supported. Ensures documents provided by GRLs and other functions conform to standard processes for the delivery of accurate, timely, and high-quality submission-ready regulatory documents.
Ensures technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted on time.
Effectively communicate to and among team members and across all levels of the organization. Develop and maintain strong collaborative relationships cross-functionally and globally.
Manage QC schedule for regulatory documents and hold team members accountable to the deliverables/timelines.
Monitor, complete, and report metrics to management as needed. Analyze metrics and recommend appropriate action (areas for improvement, trend identification, escalate areas of concern)
Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that affect Allergan’s products and operations. Advise personnel in other departments regarding their applicability and effect.
Ensure consistent approach to real-time inspection readiness by providing leadership as SME for audits/inspections.
Ensure maintenance of documentation by team in preparation and in support of audits/inspections.
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 of regulatory experience. Some portion may include relevant exposure to pharmaceutical or medical device regulatory work (e.g., other R&D role or specialized training).
Requires drug development experience in US and Canada region.
Experience working in a complex and matrix environment, and with multiple stakeholders.
Strong communication and proactive negotiation skills. Business acumen and able to work under pressure.
Experience developing and implementing successful global regulatory policies and procedures. Strong regulatory and policy foundation preferred. 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: $ 110,500 to maximum: $ 216,000)
· 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.
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.