Manager RA, Global Reg Strategy US & Canada
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
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 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. Advises on US/C region specific requirements and assesses R&D programs against region specific regulatory requirements
Responsibilities
- 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).
Qualifications :
Required Education:
- Bachelors 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 contd: Good communication both oral and written.
- Experience interfacing with government regulatory agencies.
- Demonstrates good negotiation skills and builds consensus.
Additional Information :
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.
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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Marketing
- Data Visualization
- Tableau
- Customer Segmentation
- Microsoft Powerpoint
- Investment Banking
- Strategic Planning
- Financial Modeling
- Customer relationship management
- Management Consulting
- Google Suite
- Analytics
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
