2018-01-11

Manager of Regulatory Affairs
Job Opportunity at Higher LLC

Posted on Jan 11

(424) 625-8228

Location: Schaumburg, IL
Job Type: Full Time
Job ID: W4148151

Job Summary

If you are a talented Regulatory Affairs professional with progressive experience in the pharmaceutical industries, and looking to make the next move in your career, please read on!

Why Work WIth Us?

  • We are a global leader in generic pharmaceutical development, manufacturing, and distribution.
  • Unrivaled upward mobility
  • Highly competitive compensation, benefits, and bonus package.
  • Opportunity to join a tight knit family of awesome people! We work hard, but love what we do and have a blast doing it.

Primary Duties:

  • Develop and oversee the regulatory strategy, preparation and review of FDA Submissions including Amendments, Supplements, Annual Reports, DMF updates and labeling changes, 510(k)’s and PMAs in line with regulatory requirements, regulatory guidelines, and GMP compliance
  • Post approval change control assessments
  • Review and approval of advertising and promotional materials
  • Ensuring the quickest possible approval and launch of new products
  • Management and training of Regulatory Affairs staff
  • Management of specific Regulatory Affairs programs and systems which may include: field alert reporting, management of contract manufacturers and partners, procedures and processes to ensure effective and efficient electronic submissions.

What You Need for this Position:

  • BS in Pharmacy, Microbiology, Toxicology, Chemistry, Pharmacology or related Life Sciences degree required. Advanced degree preferred.
  • 5 or more years of Regulatory Affairs experience.
  • 3 or more years of experience supervising staff. Experience supervising pharmaceutical regulatory affairs staff strongly preferred.
  • Regulatory publication eCTD software experience preferred.
  • In depth knowledge of regulatory pharmaceutical drug development process and life cycle management including strong command of CGMP’s/FDA regulations, Quality systems, FDA Guideline documents, USP, ICH and other applicable laws.
  • Pharmaceutical drug and/or device development and/or manufacturing experience; sterile injectable experience highly preferred.
  • Able to clearly articulate regulatory strategy at partner and project management meetings. Able to negotiate with partners to assure acceptance of regulatory strategy. Assures compliance with project team timelines and milestones.

So, if you think you make the cut and are ready to join a top tier company, please apply today!

Applicants must be authorized to work in the U.S.

Job Type: Full-time

Salary: $80,000.00 to $100,000.00 /year

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