Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
POSITION DESCRIPTION
Role / Position Title - Regulatory Affairs Manager - CANADA
Country - Canada
Region / City - Vaughan, Ontario
FLSA (Exempt/Non-Exempt) - Exempt
POSITION SUMMARY
Reporting to the Associate Director, Regulatory Affairs, this position is responsible for managing functional activities to ensure that the companys goals and objectives are met. This position also manages compliance within the department and ensures that global, regional, and local processes are followed. The ideal candidate understands the regulatory landscape, including its impact across business units, and is expected to communicate any changes to the regulatory environment to all relevant stakeholders.
OVERALL JOB RESPONSIBILITIES
Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.
KNOWLEDGE, SKILLS AND ABILITIES
Education:
Experience:
Skills:
Physical demands and abilities
ABOUT GLENMARK
Glenmark Pharmaceuticals is a global pharmaceutical company with a remarkable track record of achievement and improving patients lives with access to affordable medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.
Glenmark has the stability, resources and talent to work on solving serious medical problems, all while doing the right thing for patients, people and communities.
Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.
BENEFIT HIGHLIGHTS
This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Companys discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.
Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
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