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Associate Director, Regulatory Affairs

4 months ago

Manassas, Virginia, United States Catalent Pharma Solutions 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

The Candidate:

  • 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
  • Must demonstrate organizational skills, be able to interact with personnel at all levels from a variety of disciplines and be knowledgeable in cGMPs and have understanding of subject matter issues and trends
  • 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.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE ) .