Lead Regulatory Affairs Specialist- Global CMC Submissions

Scientific Protein Laboratories•Waunakee, WI

5d•Onsite

About The Position

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an on-site Lead Regulatory Affairs Specialist- Global CMC Submissions. This on-site position is responsible for supporting day to day Regulatory Affairs (RA) activities at SPL, Mobren 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. Strong oral and listening communication skills are required to support external and internal customers as well as regulatory agencies. Exceptional writing skills supporting technical subjects and regulatory documents are essential. Attention to detail and working independently with minimal supervision is required. This position reports to the RA Manager.

Requirements

3 plus years’ experience required
Bachelor’s degree in a scientific or preprofessional field required

Nice To Haves

10 plus years’ experience preferred.
Advanced degree in a scientific discipline or other technical accreditation such as Regulatory Affairs Certification preferred.

Responsibilities

Prepares global regulatory documentation and registration in support of customers and SPL business objectives.
Prepares and maintains Scientific Protein Laboratories’ (SPL) 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 SPL 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).
Possesses good computer skills and apply this knowledge to new applications as needed.
Critical thinker with attention to details and the ability to articulate regulatory position or opinion to others in multi departmental meeting.
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.
Performs other duties as assigned.