Responsible for a product(s) within a Therapeutic Area and supports the Manager (Senior Manager, Associate Director, Director (Global Regulatory Lead (GRL)), in the development & execution of the regulatory strategy.
Assigned matters may have an impact on business activities and operations.
Serves as Health Authority (HA) liaison with FDA for routine communications in support of filings including complete and timely responses during application review.
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.
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. Applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Recommends and implements changes to projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, 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 position will work a hybrid schedule (3 days in office) from our Lake County, IL AbbVie headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
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
Skill Set: Proven skill at implementing successful US and Canada regulatory strategies, global regulatory experience is a plus. Experience working in a complex and matrix environment.
Skill Set cont'd: Good communication, both oral and written.
Experience interfacing with government regulatory agencies.
Demonstrates good negotiation skills and builds consensus.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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.
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Health insuranceDental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
The Manager Regulatory Affairs, Global Reg Strategy US & Canada 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. The Manager assists Regulatory Staff by identifying and gathering 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. The Manager advises on US/C region specific requirements and assesses R&D programs against region specific regulatory requirements.
Abbvie · North Chicago, IL