Senior Representative, Regulatory Affairs
Location: Bloomington, United States
Job Category: Reg Affairs & Safety Pharmacovigilance
Job Description:
At Novo Nordisk, we want to make a difference. With more than 100 years of leadership in diabetes care, we offer life-changing careers and opportunities to improve the quality of life for millions around the world. As part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility supporting biomanufacturing and drug product fill/finish and packaging. The Bloomington campus plays a key role in the development, manufacturing, and supply of products to patients globally.
What We Offer You:
Leading pay and annual performance bonus for all positions.
Generous paid time off, including 14 paid holidays.
Health, Dental, and Vision Insurance – effective day one.
8% guaranteed 401K contribution plus individual company match option.
Family-focused benefits including 14 weeks paid parental leave and 6 weeks paid family medical leave.
Free access to Novo Nordisk-marketed pharmaceutical products.
Tuition Assistance.
Life & Disability Insurance.
Employee Referral Awards.
At Novo Nordisk, you will find ample resources, mentorship, and opportunities for career growth. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position:
The Regulatory Affairs department manages cGMP compliance and regulatory affairs for biologics, sterile injectables, cell and gene therapy, and inhalation manufacturing. The Senior Regulatory Affairs Representative serves as a regulatory liaison to clients and internal functional departments, providing regulatory strategy and support throughout the product lifecycle.
Essential Functions:
Review new and update facility drug master file(s).
Prepare high-quality documentation for client regulatory submissions.
Provide regulatory guidance and support for development and production activities.
Maintain awareness of changes in global regulatory requirements.
Review regulatory and production documents to ensure compliance with global requirements.
Serve as the regulatory liaison with applicable Health Authorities for assigned projects.
Provide written documentation of interactions with regulatory agencies.
Assist in the maintenance of facility registrations.
Develop and implement regulatory strategies to facilitate registrations and client relationships.
Serve as a regulatory resource for clients.
Perform other duties as assigned.
Qualifications:
Education/Experience:
Bachelor’s Degree required.
Master’s Degree preferred.
RAPS Certificate preferred.
5-8 years of relevant experience.
6 years’ GMP experience preferred.
Technical Requirements:
Proficient in Microsoft Word, Excel, PowerPoint, Visio.
Strong written and verbal communication skills.
Ability to manage multiple projects and deadlines.
Strong problem-solving and mathematical abilities.
Behavioral Requirements:
Results-oriented and data-driven.
Self-motivated and able to work independently and collaboratively.
Ability to manage time effectively and multitask in a fast-paced environment.
Positive attitude with a desire to collaborate and adapt.
Leadership Requirements:
Lead new hire training and drive development within the team.
Set meaningful performance objectives and provide constructive feedback.
Foster an inclusive, collaborative, and positive team environment.
Physical Requirements:
Frequent sitting, standing, walking, reading, and computer usage.
Occasional bending, carrying, and grasping.
Compliant with EHS responsibilities for the position.
Work in a controlled heating, ventilation, and air-conditioned environment.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we aspire to be the best company for the world. Our commitment to diversity and inclusion is reflected in the diverse perspectives, backgrounds, and cultures of our employees, patients, and communities we serve.
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