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Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid Onsite)
Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid Onsite)AbbVie • Great Lakes, IL, US
Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid Onsite)

Senior Manager, RA Global Regulatory Strategy US & Canada (Hybrid Onsite)

AbbVie • Great Lakes, IL, US
11 hours ago
Job type
  • Full-time
Job description

Regulatory Strategy And Planning Manager

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

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. Assures that regulatory strategies defined within the 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. This position will support the Neuroscience therapeutic area.

Responsibilities :

  • Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
  • Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion 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.
  • Functions independently in negotiation and decision-making for project related issues that have cross-functional impact. Assists in the development and training of staff members.
  • Key contributor responsible for 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.
  • Supports the regulatory submission and approval process. Broadly applies regulatory / technical knowledge of government regulations and skills across therapeutic areas.
  • Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, as well as corporate policies and management-related considerations.
  • Presents pertinent regulatory information to appropriate cross-functional areas.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

This is an onsite hybrid opportunity based in AbbVie's Lake County, IL or Cambridge, MA offices.

Qualifications :

  • Required Education : Bachelor's degree (pharmacy, biology, chemistry, pharmacology) or industry related.
  • Preferred Education : Advanced Degree a plus. Certifications a plus.
  • Required Experience : 6 years Regulatory, R&D, or Industry-related experience.
  • Preferred Experience : 2-3 years in pharmaceutical regulatory activities
  • 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.
  • Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies. Experience working in a complex and matrix environment.
  • Global regulatory experience is a plus. Experience interfacing with government regulatory agencies.

    • Additional Information :

  • 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

    • 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.

    US & Puerto Rico only - to learn more, visit Equal Employment Opportunity Employer

    US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more : Reasonable Accommodations

    Recruitment Fraud Alert :

  • AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
  • If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.

    • If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.

    Protect yourself by verifying job offers and communications. Your safety is important to us.

    Travel : Yes, 10% of the Time

    Salary : $121,000 - $230,000

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    Senior Manager Regulatory • Great Lakes, IL, US