Regulatory Affairs Specialist

Job DetailsJob Location: Scientific Protein Laboratories - Waunakee, WI 53597JOB SUMMARY   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 a Regulatory Affairs Specialist.   This 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 is 100% on-site.   Responsibilities include: Prepares global regulatory documentation and registration in support of customers and SPL business objectives. Prepares and maintains Drug Master Files (DMF) for U.S. FDA. 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. Responsible for reviewing Quality Systems documents such as Change Controls and assessing applicability to the RA department. Assists with reports and recommendations supporting updates and changes to evolving regulatory requirements. 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.   Job Requirements and Qualifications:   Education: Bachelor’s degree in a scientific or preprofessional field required Experience:  2 plus years applicable GMP experience   WHY JOIN SPL? 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. Qualifications