REMOTE Senior Regulatory Affairs Project Manager – Infant Formula and OES

Regulatory Affairs/Clinical Affairs Charlottesville, Virginia


Descripción

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

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

 Key Responsibilities

  • 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.
  • Collaborate with the project teams to develop regulatory strategies, milestones and submission deliverables for the development of new nutritional products.
  • Negotiate directly with FDA, and other health authorities, to resolve regulatory and registration issues, domestic and international.
  • Interface with external regulatory groups (e.g. consultants, industry associations, government agencies, etc.) to guide preparation of regulatory documentation.
  • Responsible for claims, to ensure compliance with regulations, corporate standards, policies and business objectives.
  • 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.
  • Prepare, review and approve product labels
  • Review and approve content for websites, advertisements, commercials, handouts, mailers, etc. for compliance.
  • 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.

 Knowledge and Experience

  • Must possess advanced analytical skills, 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
  • Advanced verbal and written presentation and communication skills necessary. Ability to convey information in a clear, focused and concise manner.
  • 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 8-10 years of experience in the health care or pharmaceutical industry and 5-7 years of hands on experience in regulatory affairs. 
  • Advanced degree preferred.
  • Experience in nutrition, specifically infant nutrition preferred

#DIV

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.