Catalent Pharma Solutions

Regulatory Affairs Specialist

Position Summary

Catalent Pharma Solutions is hiring a Regulatory Affairs Specialist. The Regulatory Affairs Specialist is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory aspects and climate that would affect proposed activities. The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will be based at the Harmans-BWI campus. The Harmans-BWI campus features two manufacturing facilities that support clinical through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Responsibilities will include with oversite authoring, review, and preparation of applications for clinical through commercial submissions globally. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.

This is a full-time position: Monday – Friday, Days.

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.

The Harmans-BWI campus is one of the sites that support Phase 3 through commercial manufacturing of advanced therapeutic products. People joining our team will have the opportunity for career development as our business continues to grow and expand.

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 Role

• Plan, coordinate, and drive the development and evaluation of assigned components of new drug substance and drug product regulatory strategies and submissions from development through commercialization

• Manage resources and ensure appropriate review and oversight for multiple submission components within the Catalent portfolio. Work closely with management, customers, and strategic partners to ensure the needs of Catalent, regulatory bodies and customers are appropriately considered and delivered against

• Supports regular quality audits and develop quality management systems in compliance with pharmaceutical standards for GMP (Good Manufacturing Practices) / GLP (Good Laboratory Practices)

• Evaluate changes to procedures and products for impact to regulatory filings. Evaluate document request and provide appropriate documents in support of client and regulatory agency audits.

• Actively participate in client and regulatory agency audits.

• Conduct assessments and identify areas of improvement to regulatory aspects of drug development and commercial operations; propose and implement process improvements

• All other duties as assigned;

The Candidate

• Bachelor’s Degree in in a life science with 5+ years of experience in Regulatory Affairs, Quality Assurance or related field or any combination in a manufacturing, pharmaceutical and/or GMP facility required.

• Ability to interpret subjective and complex aspects of specific regulations and thorough understanding of regulations is highly desired

• Experience interpreting technical documents/validation protocols preferred

• High level attention to detail while managing multiple projects and/or priorities under tight deadlines is a must

• Possess good communication and problem-solving skills highly desired.

• Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required

• Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 152 hours of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Competitive salary

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• GymPass program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .