Senior Representative, Regulatory Affairs
Location: Bloomington, United States
Job Category: Reg Affairs & Safety Pharmacovigilance
About the Department:
Novo Nordisk has led the way in diabetes care for over 100 years, and being part of Novo Nordisk means embarking on life-changing careers. At the Catalent, Indiana LLC. facility in Bloomington, we integrate processes from formulation to commercial biomanufacturing, offering a dynamic work environment. Join us to help improve the quality of life for millions of people worldwide.
What We Offer You:
Competitive pay and annual performance bonuses
Generous paid time off, including 14 paid holidays
Health, Dental, and Vision Insurance – effective day one
8% 401K contribution plus individual company match
Family-focused benefits, including paid parental and family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition assistance and life & disability insurance
Employee referral awards
At Novo Nordisk, you will find mentorship and resources to help grow your career. Join Team Novo Nordisk to make a meaningful impact on healthcare!
The Position:
As a Senior Representative in Regulatory Affairs, you will be responsible for managing and guiding the organization’s cGMP compliance and regulatory affairs for biologics, sterile injectables, cell and gene therapy, and more. You 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.
Key Responsibilities:
Review and update facility drug master file(s)
Prepare accurate documentation for client regulatory submissions
Provide regulatory guidance and support for development and production activities
Stay updated on global regulatory requirements for effective submissions and production documentation
Serve as regulatory liaison with Health Authorities for assigned projects
Maintain facility registrations and develop regulatory strategies for registrations and client relationships
Provide written documentation of interactions with regulatory agencies
Serve as a regulatory resource for clients
Qualifications:
Education/Experience:
Bachelor's Degree required, Master's Degree preferred
RAPS Certification preferred
5–8 years of relevant experience, with at least 6 years of GMP experience preferred
Technical Skills:
Proficient in Microsoft Word, Excel, PowerPoint, Visio
Excellent written and verbal communication
Ability to prioritize and manage multiple complex projects
Strong problem-solving and mathematical skills
Behavioral Requirements:
Results-oriented, self-motivated, and detail-oriented
Ability to collaborate and work independently in a fast-paced environment
Positive attitude and flexibility to adapt to changes
Leadership Requirements:
Lead new hire training and development within the team
Set meaningful performance objectives for direct reports
Provide constructive feedback and coaching to enhance team capabilities
Establish effective and professional relationships across teams
Physical Requirements:
Frequent sitting, standing, walking, and computer use
Occasional stooping, kneeling, and carrying
Compliance with EHS responsibilities for the position
Equal Opportunity Employer:
Novo Nordisk is an equal opportunity employer, offering equal consideration for employment without regard to race, ethnicity, gender, disability, or other protected status.
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