Manager, Regulatory Affairs Job in North Wales 19436, Pennsylvania Us
JOB DESCRIPTION:
Overview:
Teva Pharmaceuticals USA is the leading generic pharmaceutical company, marketing products from a wide range of therapeutic areas including analgesic, anti-infective, cardiovascular, oncology, CNS, dermatological and anti-inflammatory. Teva USA products are marketed to chains, wholesalers, distributors, hospitals, managed care entities, and government agencies. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals.
Responsibilities:
Teva Pharmaceuticals USA is looking for a Manager, Regulatory Affairs for our North Wales, PA facility. This position will be responsible for the regulatory assessment of change control for approved ANDAs and will direct the preparation, review, and approval of submissions to FDA.
Responsibilities will include:
* Evaluate change controls and provide final regulatory assessment. * Review ANDAs, Amendments, Supplements, Annual Reports, Control Documents, etc. for FDA submissions.
* Provide regulatory guidance to Project Teams, RD, Process Engineering, Package Engineering, Marketing, Supply Chain, etc.
* Directly Manage up to 5 Regulatory Specialists and collaboratively supervise the activities of approximately 20 Regulatory Specialists.
Qualifications:
- PharmD/BS degree in a scientific discipline.
- Minimum 5 years pharmaceutical industry experience: 2 years Analytical, QA, laboratory, or production experience preferred and 4 years Regulatory Affairs experience preferred.
- Injectable/sterile product experience required
- Managerial experience preferred
- Exhibits strong knowledge of current regulations and guidances related to the filing, approval process, and maintenance of ANDAs.
- Demonstrates a basic understanding of pharmaceutical drug development.
- Basic computer skills such as Word, Excel, Power Point, and familiarity with the internet.
- Ability to manage timelines within a project team environment.
- Ability to work independently and on teams.
- Ability to effectively liase with FDA, various disciplines within Teva, and third parties.
- Ability to establish and maintain good working relationships.
- Demonstrates good negotiation and management skills.
- Good verbal and written communication skills.
Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.
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