Regulatory Affairs Project Manager
Allegan, MI, US, 49010
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care.
Description Overview
An exciting career opportunity is currently available on the Regulatory Affairs (RA) team for Perrigo. The Project Manager position is responsible for the hands on regulatory activities required to approve and launch new Dietary Supplement products and for the maintenance of existing commercialized Dietary Supplement products for the Consumer Healthcare business units. The Project Manager executes regulatory activities according to project plans to assure new products meet launch goals. Related activities include attending project team meetings, developing basis for marketing rationales, developing labeling specifications, hands on regulatory activities required to maintain existing commercial products, and review/approval of promotional material labeling.
Scope of the Role
This position also:
- 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
Experience Required
- Bachelor degree (BS or BA) in an applicable scientific or health science field such as biochemistry, chemistry, pharmacy or pharmacology. Preference given to degrees in Nutritional Science, Dietetics, or similar field.
- 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.
- Minimum of three (3) years experience with dietary supplements – both in evaluating new products for basis for marketing and labeling
- 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
Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about Total Rewards at Perrigo.
Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.
We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV #weareperrigo
Nearest Major Market: Grand Rapids