Regulatory Affairs Project Manager, Infant Formula and OES

Location:

Charlottesville, VA, US, 22911

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.

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Description Overview

Responsible for the hands on regulatory activities associated with bringing new Infant Formula and Oral Electrolytes products to market and commercial product maintenance. Projects are of moderate to significant complexity and may include developing recommendations on regulatory strategy for a product category or therapeutic area.

Scope of the Role

Manage regulatory activities that support the development of new and maintenance of existing commercialized products in consumer healthcare, foods, dietary supplements, oral electrolytes and infant formula.
Serve as Regulatory point of contact on project teams to develop regulatory strategies, milestones and submission deliverables for the development of new nutritional products.
Responsible for developing compliant labeling and review content for websites, advertisements, commercials, handouts, and mailers, etc. for compliance
Negotiate directly with FDA, and other health authorities, to resolve regulatory and registration issues, domestic and international.
Review and approve raw materials for allergen statements, genetically modified organisms, irradiation, etc.
Author Standard Operating Procedures (SOP) and Standard Work Instructions (SWI) for Regulatory Affairs department, as needed. Includes the biannual review, and revisions, to existing SOPs and SWIs.
Monitor and interpret the impact of ongoing development in the regulatory environment and work with internal and external stakeholders on impact of new laws and regulations.
Support investigation of quality, product safety and / or regulatory issues arising from partners, customers, retail stores or regulators. Support implementation of corrective actions and procedure improvements to resolve issues.

Experience Required

Background in nutrition desirable.
Familiarity with Infant Formula regulations and experience with Infant Formula Notifications highly desirable.
Must possess advanced analytical skills, communication/writing, and critical thinking and the ability to identify and apply policies and general regulations to specific products and projects
Ability to monitor, analyze, raise awareness and assess impact of regulatory issues for stakeholders inside and outside of Regulatory Affairs
Ability to effectively lead project teams is required.
Ability to utilize business acumen in decision making
Proactive and self-motivated with a collaborative attitude and a desire to continuously learn.
These skills are normally acquired through possession of a bachelor’s degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology, or nutrition or food sciences combined with 5+ years of experience in the health care or pharmaceutical industry and 5+ years of hands on experience in regulatory affairs.
Advanced degree preferred.

External 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 seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better. #DIV