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 Director, Regulatory Affairs CMC you will be responsible for developing and implementing regulatory strategies for US CMC activities throughout the product lifecycle. This includes providing guidance on regulatory expectations for drugs, biologics, combination products and medical devices and review of documents to support Health Authority submissions. This position provides overall leadership of US RA-CMC across the Ferring portfolio. This role is an individual contributor role, leading cross-functional CMC teams and mentoring peers, but may have direct reports in the future.

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.

Responsibilities:

• CMC Regulatory Strategy: Partner with key stakeholders to develop and implement CMC regulatory strategies and plans for CMC projects. Develop solutions to regulatory or business problems where no clear precedence exists.

• Submissions for Development and Commercial Products: Lead activities, including planning and reviewing US CMC sections of all regulatory submissions (i.e. INDs, NDAs, BLAs meeting requests, briefing documents and supplements) to support US clinical trials and product registrations. Coordinate the preparation and timely submission of responses to regulatory agencies.

• Support change management: Represent regulatory CMC on and/or lead matrix teams on all US CMC related issues. Assess manufacturing change controls for US impact and guide technical teams on practical aspects of change management.

• CMC regulatory compliance: Communicate and interpret new regulations or regulatory guidance and assess impact of changes. Assist in FDA inspections and planning.

• Effective stakeholder management: Establish and maintain sound working relationships internally with Ferring and externally with FDA and lead all CMC related regulatory agency interactions in the US.

Requirements:

• Bachelors' degree required. Masters' degree preferred.

• 10+ years of industry experience and 7-10 years in Regulatory CMC.

• Direct experience with all types of CMC regulatory documents and sections (INDs, NDA, BLA, supplements, and responses) in eCTD format.

• Must have experience in regulatory CMC for sterile products and biologics.

• Solid working knowledge of drug development to support pre- and post-approval CMC activities.

• Proven experience in leading FDA regulatory interactions and negotiations.

• Excellent written and verbal communication skills.

• Strong interpersonal skills to lead matrix teams and task forces, resolve conflicts, and influence decision making to keep projects on track. Must have a sense of urgency to drive projects to completion.

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $174,000 to $254,150, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 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 as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.

Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.