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Associate Director, Regulatory Affairs

4 months ago

Somerset, United States Catalent Full time

**Associate Director, Regulatory Affairs**

**Position Summary**:
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The primary duty of the **Associate Director, Regulatory Affairs** is to support regulatory strategy for product development and manufacturing activities for the Cell & Gene Therapy sites to ensure compliance with GMP regulations and to support preparation and filing of regulatory submissions for clients.

The **Associate Director, Regulatory Affairs** will be interpreting and evaluating reports and other documents to be used in all typical regulatory submissions, reviewing new and revised SOPs and guidance pertaining to Regulatory Affairs and regulatory compliance. Will prepare for and lead regulatory meetings, designing regulatory compliance strategy to ensure compliance with GMP regulations, assisting in training of regulatory department and cross-functional areas in regulatory requirements. The **Associate Director, Regulatory Affairs** will review change control for potential impact on client or company submissions, providing regulatory guidance and support for development and production activities, interacting with clients, and maintaining awareness of changes in regulatory requirements for effective regulatory submissions

**The Role**:

- Prepare, review, manage and oversee submissions
- Preparation of responses to objections/questions issued by regulatory authorities
- Facilitate development of company position on emerging or new regulations
- Provide expert advice on regulatory strategies at all phases of development
- Preparation, submission, and follow up in conjunction with clients in support of meetings with regulatory authorities
- Provide regulatory strategy solutions to Catalent sites and their clients
- Provides tactical & limited strategic direction up to 3-6+ months in advance
- Upwards to 20% travel expectations (domestic & international)
- Other duties as assigned
- Bachelor’s degree in Chemistry, Biology, Engineering or equivalent, required
- 8 + years within the Pharmaceutical or related industry ; 5+ years in regulatory role
- 5+ years of leadership
- Strong technical competencies and communication skills are required; demonstrated competence in both written and verbal communication is required
- Demonstrated experience and sound knowledge of GMP regulations and multi-national regulatory submission requirements
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
- (PEOPLE LEADER ROLES) Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

**Why You Should Join Catalent**:

- Several Employee Resource Groups focusing on D&I
- Potential for career growth within an expanding team
- Diverse, inclusive culture
- 152 hours of PTO + 8 Paid Holidays

**Catalent offers rewarding opportunities to further your career** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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