Regulatory Affairs Manager
About The Position
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease. As the Regulatory Affairs Manager you will represent Regulatory Affairs for pharmaceutical development projects and marketed products as assigned. Working with development teams, identifying and compile required documentation for regulatory submissions. Serve as regulatory subject matter expert to advise technical operations on regulatory best practices for pharmaceutical development and cGMP manufacturing. Actively participate and potentially lead cross functional teams and regulatory projects. With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.
Requirements
- BS degree or equivalent in a scientific field; microbiology, pharmacology specialization a plus.
- 3 years of regulatory experience; augmentable with quality or CMC development experience; experience in microbiome therapeutics is highly regarded.
- Subject Matter Expertise: pharmaceutical product development, regulation, quality; medical, regulatory, or other technical writing; expertise in live biotherapeutics a plus; project management expertise a plus
Nice To Haves
- Degree in regulatory affairs or advanced degree is preferred.
- expertise in live biotherapeutics a plus
- project management expertise a plus
Responsibilities
- Support CMC-themed regulatory interactions (submissions and responses) from regulatory agencies (FDA and global) by providing CMC and regulatory expertise.
- Interface with Roseville CMC teams to better understand process development and status so as to better support regulatory interactions.
- Organize and coordinate SME meetings in preparation for regulatory interactions (preIND, SNSA, ITF…)
- Evaluate microbiome-related change control documents for regulatory impacts or perspectives.
- Interface with global regulatory to align clinical and CMC perspectives.
- Participate in program development team meetings to reach decisions on regulatory submission strategies.
- Author and coordinate authoring of CMC regulatory submission documents.
Benefits
- competitive total compensation
- exceptional range of flexible benefits
- personal support
- tailored learning and development opportunities
- working hours that respect your lifestyle
- welcoming and equitable culture
- comprehensive healthcare (medical, dental, and vision)
- 401k plan and company match
- short and long-term disability coverage
- basic life insurance
- wellness benefits
- reimbursement for certain tuition expenses
- sick time of 1 hour per 30 hours worked
- vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment
- 15 paid holidays per year
- paid parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Associate degree
