Regulatory Affairs Specialist

Are you a regulatory affairs professional looking to support a unique raw material manufacturing company?

This on-site position is responsible for supporting day-to-day regulatory affairs activities at our client's company, as well as supporting external customer requests. Responsibilities for this role include maintaining and responding to established timelines for reports such as Drug Master Files (DMF) and annual updates/amendments.

This is a full-time, permanent opportunity.

Responsibilities include:

• Prepares global regulatory documentation and registration in support of customers and business objectives.
• Prepares and maintains Drug Master Files (DMF) for U.S. FDA and similar documents for other countries as applicable.
• Keeps with current EC drug substance or Active Pharmaceutical Ingredient (API) regulatory requirements.
• Keeps current with Code of Federal Regulations (CFR) requirements for applications to DMF, IND and NDA documents.
• Participates and supports customer and regulatory agency inspections.
• RA Manager designee for reviewing Quality Systems documents such as Change Controls and assessing applicability to the RA department.
• Prepares document packages for clients in support of DMF, IND and NDA filings.
• Collects, reviews, interprets and summarizes data, deviations/discrepancies, change control records, procedure history files, and other appropriate documentation pertinent to the support of Annual Update in accordance with company procedures.
• Serves as a Regulatory Affairs advisor to the Change Control Committee and various task forces involved in quality improvement.
• Responsible for using electronic submissions formats such as Electronic Common Technical Document (ECTD).
• Maintains knowledge about regulations and regulatory trends for the U.S.A, Canada and European Commission.
• Maintains knowledge about USDA importation and exportation requirements.

Education and Qualifications:

• 3 years’ experience required
• Bachelor’s degree in a scientific or preprofessional field required; advanced degree preferred.