Manager Global Regulatory Strategy US Canada Hybrid Onsite
Manager Global Regulatory Strategy US Canada Hybrid Onsite
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Salary Not Disclosed
1 Vacancy
Job Description
The Manager Global Regulatory 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. 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 and 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 decisionmaking for project related issues that have crossfunctional 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 guidance as well as corporate policies and managementrelated considerations.
- Presents pertinent regulatory information to appropriate crossfunctional 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 a hybrid onsite opportunity. The role can be based in AbbVies office in San Francisco Irvine CA or Lake County IL.
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 Industryrelated experience.
- Preferred Experience: 23 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 serving our community and embracing diversity and inclusion. It is AbbVies 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 protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
