Regulatory Affairs Manager

About the role

As the Regulatory Affairs Manager you will represent Regulatory Affairs for pharmaceutical development projects and marketed products as assigned. You will work with development teams to identify and compile required documentation for regulatory submissions, serve as a regulatory subject matter expert to advise technical operations on regulatory best practices for pharmaceutical development and cGMP manufacturing, and actively participate in or lead cross-functional teams and regulatory projects.

Ferring is a privately-owned, biopharmaceutical company pioneering life-changing therapies that help people build families and live better lives. Our independence fosters an entrepreneurial spirit and long-term perspective, enabling growth and agility while staying true to our ‘people first’ philosophy. With over 70 years of commitment to science and research, Ferring drives powerful discoveries and therapies to combat disease. Ferring US is Great Places to Work® Certified and has been recognized by Fast Company as one of “The World’s Most Innovative Companies” and by Fortune on its “Change the World List” for addressing society’s unmet needs.

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 to 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.

Requirements

• BS degree or equivalent in a scientific field; microbiology or pharmacology specialization a plus. Degree in regulatory affairs or an advanced degree is preferred.
• 3 years of regulatory experience; quality or CMC development experience may augment this. Experience in microbiome therapeutics is highly regarded.
• Subject matter expertise in pharmaceutical product development, regulation, quality, medical, regulatory, or other technical writing. Expertise in live biotherapeutics and project management is a plus.

Benefits

• Comprehensive healthcare (medical, dental, and vision) with a premium differential inverse to base salary.
• 401k plan with company match.
• Short and long-term disability coverage and basic life insurance.
• Wellness benefits and reimbursement for certain tuition expenses.
• Sick time accrual of 1 hour per 30 hours worked.
• Vacation time: up to 120 hours in the first four years of employment, and 160 hours in the fifth year.
• 15 paid holidays per year.
• Paid parental leave subject to a minimum period of employment at Ferring.

Pay

The base salary range for this role is $119,575 to $222,067. The actual amount paid may differ based on experience, knowledge, skills, abilities, education, and primary work location. Additional compensation includes competitive annual incentive compensation targets in the form of an annual bonus, with payouts based on individual and company performance.

Location: Roseville, Minnesota