Cellular Dynamics International (CDI), a FUJIFILM company, is a leading developer and supplier of human cells used in basic and translational research, drug discovery, toxicity testing, and regenerative medicine applications. Leveraging technology that can be used to create induced pluripotent stem cells (iPSCs) and differentiated tissue-specific cells from any individual, CDI is committed to advancing life science research and transforming the therapeutic development process in order to fundamentally improve human health. The company’s inventoried iCell® products and donor-specific MyCell® Products are available in the quantity, quality, purity, and reproducibility required for drug and cell therapy development. For more information please visit www.cellulardynamics.com.
Cellular Dynamics, a FujiFilm Company, is currently hiring for a Regulatory Affairs (RA) Manager position at our Madison, WI location. The Regulatory Affairs (RA) Manager is responsible for planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within CDI timelines and in accordance with regulatory guidelines and applicable federal laws. In addition, the RA manager provides regulatory strategy to CDI as required, as well as stays current with global regulatory rules and guidance, providing a regulatory intelligence role for CDI.
Some of the responsibilities are, but not limited to:
Essential Job Responsibilities
1. Lead strategic regulatory efforts for CDI such as coordinating and preparing regulatory submissions, providing regulatory intelligence, as well as developing and implementing regulatory policy.
2. Act as primary liaison between CDI and regulatory agencies by receiving and disseminating regulatory body feedback and working with internal teams to craft and deliver responses.
3. Train staff in regulatory policies and/or procedures.
4. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensive, or compliance with regulatory standards.
5. Establish regulatory priorities or budgets and allocate resources and workloads.
6. Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
7. Contribute to the development or implementation of business unit strategic and operating plans.
8. Participate in the development and/or implementation of clinical trial protocols.
9. Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate, and pediatric plan).
10. Develop and mentor staff reporting to role.
11. Perform other duties as required.
Essential Job Requirements:
1. Bachelor of Science in Biology or related field.
2. At least three years of experience with a Master’s Degree or five years of experience with a Bachelor’s Degree in Regulatory Affairs in the biotechnology or pharmaceutical industries.
3. Regulatory interaction and submissions experience required.
4. Working knowledge of 21CFR Part 58.
5. In-depth knowledge of sections of the Code of Federal Regulations that apply to cell therapeutics, HCT/Ps, and gene therapeutics (21 CFR 210/211, 600/610, and 1271) in addition to related guidance documents.
6. Ability to identify, define, and solve problems; trouble-shoot, lead, influence and inspire people.
7. Experience hiring and managing a team of people.
8. Excellent written and oral communication skills.
9. Skilled in conflict management.
10. Excellent project management abilities.
11. Expertise using MS WORD.·
12. Ability to travel.
Cellular Dynamics International Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.