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:
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.
- Represent department on pre-approval and post-approval project team meetings
- Supervise associate level personnel
Qualifications:
Position Requirements
- PharmD/BS degree in a scientific discipline.
- Minimum 5 years pharmaceutical industry experience and at least 2 years regulatory affairs experience
- Supervisory experience preferred but not required
- 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 liaise 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.
