Regulatory Affairs Project Manager Position Summary Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager. The Regulatory Affairs Project Manager 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 Project Manager combines knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. This is a full-time position: Monday – Friday, Days. This is a remote position. 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. This position will be supporting both the Biologics and Cell and Gene Therapy sites throughout the Catalent network for clinical and commercial applications. Responsibilities will include authoring, review, and preparation of applications for clinical through commercial submissions globally. The role is expected to lead projects across multiple sites. 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 Lead the development of regulatory strategy for innovative regulatory filings. Identify potential risks and mitigation strategies in regulatory filings and appropriately communicate to internal team and client. Evaluate document request and provide appropriate documents in support of client and regulatory agency audits. Evaluate changes to procedures and products for impact to regulatory filings. Actively participate in client and regulatory agency audits. Utilize data to identify process improvements, risk mitigations and changes to regulatory standards. Proactively interact and negotiate with internal review teams/SMEs to ensure positive outcomes for submissions. Lead discussions with RA and project teams to mitigate gaps between regulations and current processes and procedures. Responsible for the finances of the assigned projects. Prepare annual product reports and ensure on time closure Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure All other duties as assigned; The Candidate Required a Bachelor’s Degree in Life Sciences with 5 years of experience in premarket regulatory affairs CDMO knowledge, Biologics and Cell Gene Therapy experience highly preferred Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of associated regulations required. High level attention to detail while managing multiple projects and/or priorities under tight deadlines is a must 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. 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 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. Catalent = Catalyst Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if… You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT). You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world! You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people. You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first. You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU! See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.