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Regulatory Affairs Project Manager ( Labeling / ANDA / NDA)

An exciting career opportunity is currently available on the Regulatory Affairs (RA) team at Perrigo's US Headquarters in Allegan, Michigan.  The Project Manager position isresponsible for the hands on regulatory activitiesrequired to submit, approve and launch new products and for the maintenance of existing commercialized products for the ConsumerHealthcare business unit.  TheProject Manager executes regulatory activities according to project plans to assure new products meetsubmission, approval and commercial launch goals.  Related activities include compiling and writing ANDA and NDA submissions, review/approval of promotional material labeling, and 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 activitiesrequiredto 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 AffairsProject Manager requirements: Bachelordegree (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 and relevant practical training in the field, is required. Minimum of four (4) plus years of experience with Perrigo or another company in the pharmaceutical, medical device or other medical products/health care 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
Salary Range: NA
Minimum Qualification
Less than 5 years

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