20 days old

Regulatory Affairs Project Manager (ANDA/NDA)

Perrigo
Allegan, MI 49010
  • Job Code
    125952872
Perrigo

Perrigo Company is dedicated to making lives better by bringing quality, affordable self-care products that consumers trust everywhere they are sold. Help us do it.


Please note: This position may be filled at an Associate Project Manager level, a Project Manager level, or a Senior Project Manager level depending on the experience/skills/abilities of the selected candidate(s). The qualification requirements shown below are reflective of the Project Manager level.

An exciting career opportunity is currently available on the Regulatory Affairs (RA) team at Perrigos US Headquarters in Allegan, Michigan. The Project Manager position is responsible for the hands on regulatory activities required to submit, approve and launch new products and for the maintenance of existing commercialized products for the Consumer Selfcare business unit. The Project Manager executes regulatory activities according to project plans to assure new products meet submission, approval and commercial launch goals. Related activities include compiling and writing ANDA and NDA submissions as well as communicating directly with FDA during the review and approval process. Related activities include attending project team meetings, developing basis for marketing rationales, developing labeling specifications, and other hands-on regulatory activities required to maintain existing commercial products.

This position also:

  • supports manufacturing and procurement in the management of change to existing commercial products by managing, compiling and writing post-approval submissions
  • maintains product labeling in compliance with laws and regulations
  • develops and approves labeling specifications in compliance with SOPs
  • negotiates directly with FDA and other health authorities to resolve regulatory issues
  • maintains regulatory files and data systems in compliance with SOPs
  • acts as a representative of Regulatory Affairs in project team meetings


Regulatory Affairs Project Manager requirements:

  • Bachelor degree (BS or BA) in an applicable scientific or health science field such as biochemistry, chemistry, pharmacy or pharmacology
  • Some hands-on experience in Regulatory Affairs, or a combination of an advanced degree in Regulatory Affairs or related field and relevant practical training in the field, is required.
  • Minimum of four (4) or more years of experience with Perrigo or another company in the pharmaceutical, medical device or other medical products/health care/selfcare industry with progressive experience managing projects of complexity, is required.
  • Excellent analytical skills and the ability to apply policies and general regulations to specific products or projects.
  • Good verbal and written communication skills
  • Ability to work effectively on project teams
  • Knowledge and understanding of scientific, regulatory and trade dress terminology

#DIV
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Equal Employment Opportunity/M/F/disability/protected veteran status.

PI125952872

Categories

Posted: 2020-11-12 Expires: 2020-12-13

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Regulatory Affairs Project Manager (ANDA/NDA)

Perrigo
Allegan, MI 49010

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