Senior Regulatory Affairs Representative

Company: Disability Solutions
Location: Bloomington
Posted on: October 3, 2024

Job Description:

Senior Regulatory Affairs RepresentativePosition 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.----Our state-of-the-art facility in Bloomington, Indiana provides a fully integrated model from process and formulation development to clinical and commercial biomanufacturing and drug product fill/finish and packaging. Catalent's North American Center of Excellence for early-phase clinical biologics formulation development and drug product fill/finish houses a fully automated small-scale filling line for Phase 1 and 2 programs, as well as a best-in-class formulation development lab, quality control lab, packaging, and cold storage.Catalent Pharma Solutions in Bloomington, IN is hiring Regulatory Affairs Senior Representative who is accountable for direct management and guidance regarding the organization's cGMP compliance and regulatory affairs for biologics, sterile injectables, cell and gene therapy, inhalation manufacturing and analytical services.---- Regulatory Affairs will work with clients and internal cross-functional teams to provide regulatory strategy and support services for drug and combination products throughout the product lifecycle.This is a full-time role position: Monday - Friday, days.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

• The main responsibility of a Senior Regulatory Affairs specialist is to serve as a regulatory liaison to clients and internal functional departments;
• Review new and update facility drug master file(s);
• Prepare accurate and quality documentation for client regulatory submissions;
• Provide regulatory guidance and support for development and production activities;
• Maintain awareness of changes in global regulatory requirements for effective regulatory submissions and production documentation;
• Review regulatory and production documents to ensure compliance with global requirements, agreements, and other regulations;
• Serve as regulatory liaison with the applicable Health Authorities for assigned projects;
• Develop and implement regulatory strategies to facilitate registrations and client relationships.
• Serve as a regulatory resource for clients
• All other duties as assigned;The Candidate
  • Bachelor's Degree required, Master's Degree preferred;
  • 5+ year's of relevant experience required, 6 years' of GMP experience preferred;
  • RAPS Certificate preferred;
  • Must be able to read and understand English - written job instructions and safety requirements;
  • Proficient computer skills (Microsoft Word, Excel, PowerPoint, Visio, etc.);
  • Ability to prioritize and manage multiple projects of varying complexity, where process and/or
  • deliverables may be nonstandard;
  • Strong problem-solving skills and mathematical abilities;
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;Why you should join Catalent:
    • Defined career path and annual performance review and feedback process--
    • Diverse, inclusive culture--
    • 152 Hours 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 categoriesCatalent 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.--personal initiative. dynamic pace. meaningful work.Visit 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Louisville , Senior Regulatory Affairs Representative, Other , Bloomington, Kentucky