Regulatory Affairs Specialist

Scientific Protein Laboratories (SPL) is a world leader in biosourced pharmaceuticals, seeking a highly skilled Regulatory Affairs Specialist to join our team in Waunakee, WI. As a key member of our Regulatory Affairs department, you will be responsible for supporting day-to-day activities, including 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, and other regulations.

• Prepare global regulatory documentation and registration in support of customers and SPL business objectives.
• Prepare and maintain Scientific Protein Laboratories' (SPL) Drug Master Files (DMF) for U.S. FDA and similar documents for other countries as applicable.
• Stay current with EC drug substance or Active Pharmaceutical Ingredient (API) regulatory requirements.
• Stay current on U.S. FDA cGMP requirements.
• Stay current with Code of Federal Regulations (CFR) requirements for applications to DMF, IND, and NDA documents.
• Participate and support customer and regulatory agency inspections.
• RA Manager designee for reviewing Quality Systems documents such as Change Controls and assessing applicability to the RA department.
• Prepare document packages for clients in support of DMF, IND, and NDA filings.
• Collect, review, interpret, and summarize 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.
• Serve as a Regulatory Affairs advisor to the Change Control Committee and various task forces involved in quality improvement.
• Support the SPL Contract Manufacturing and Research & Development groups with appropriate regulatory functions.
• Independently organize, manage, and meet critical timelines for regulatory activities.
• Responsible for using electronic submissions formats such as Electronic Common Technical Document (ECTD).
• Possess good computer skills and apply this knowledge to new applications as needed.

• Position will be filled up to the Lead level and determined at discretion of the hiring manager.
• Experience: 3 plus years' experience required; 10 plus years' experience preferred.
• 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.

Our employees are our success. We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

Perks include: competitive compensation; excellent benefits package - including Medical, Dental, and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law.