The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.
Responsibilities:
- This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy. Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
- Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
- Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel. May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
- Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
- Operates independently, with recognition of when to consult management. Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
- Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review. Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
- Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Presents pertinent regulatory information to appropriate cross-functional teams.
- Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
Minimum Qualifications:
- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
- 5+ years Regulatory, R&D, or equivalent industry-related experience.
- Experience in medical device space
- Experience with digital health/software
- Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience working in a complex and matrix environment.
- Experience interfacing with government regulatory agencies.
Preferred Qualifications:
- Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
- Global regulatory experience is a plus.
Other Required Skills:
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
- Able to deliver challenging messages effectively without compromising important business relationships.
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 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 and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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