Lead Regulatory Affairs Specialist

Job Description

This on-site position is responsible for supporting day-to-day Regulatory Affairs activities at the company and its transportation service partner, as well as supporting external customer requests. Responsibilities include maintaining and responding to established timelines for reports such as Drug Master Files (DMF) and annual updates/amendments in compliance with ICH Q7, 21 CFR 314.420 and other regulations as applicable. This position reports to the RA Manager.

Responsibilities include:

• Prepares global regulatory documentation and registration in support of customers and Fbusiness 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 on U.S. FDA cGMP 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.
• Supports the Contract Manufacturing and Research & Development groups with appropriate regulatory functions.
• Independently organizes, manages and meets critical timelines for regulatory activities.
• 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 EC.
• Maintains knowledge about USDA importation and exportation requirements.
• As needed assists with Annual Product Reviews (APR) and ensures correct information is captured in the regulatory files.

Education and Qualifications:

• Experience: 3 plus years’ experience required; 10 plus years’ experience preferred.
• Education: Bachelor’s degree in a scientific or preprofessional field required; advanced degree in a scientific discipline or other technical accreditation such as Regulatory Affairs Certification preferred.