Senior Representative, Regulatory Affairs

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.  

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance 
8. Life & Disability Insurance
9. Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.

The Position

The Regulatory Affairs department is accountable for the 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. The main responsibility of the Senior Regulatory Affairs Representative is to serve as a regulatory liaison to clients and internal functional departments.

Relationships

Reports to: Associate Director, Regulatory Affairs

Essential Functions

• 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
• Provide written documentation of interactions with regulatory agencies
• Assist in the maintenance of facility registrations
• Develop and implement regulatory strategies to facilitate registrations
• Develop and implement regulatory strategies to facilitate client relationships
• Serve as a regulatory resource for clients
• 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
  • Must be able to read and understand English-written job instructions and safety requirements
• Technical Requirements:
  • Proficient computer skills (Microsoft Word, Excel, PowerPoint, Visio, etc.)
  • Excellent written and verbal communication
  • 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
  • Desire to go above and beyond and not only meet, but exceed, client expectations

• Behavioral Requirements:
  • Results-oriented and data-driven
  • Self-motivated and able to lead, follow up, and drive document generation to completion with manager support, as needed
  • Detail-oriented with strong ability to multi-task within a fast-paced environment with multiple competing deadlines
  • Ability to effectively communicate in English, including the ability to see, hear, read, and write clear English and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with manager, group members, and other departments, as necessary
  • Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
  • Ability to cooperate with coworkers within an organized team environment or work independently
  • Positive attitude and desire to collaborate across departments and Catalent facilities
  • Ability to process a large volume of work
  • Flexible and adaptable to effectively operate within a rapidly growing and continually evolving business
  • Ability to put aside personal opinions and focus on business, department, and/or group needs
• Leadership Requirements:
  • Leads new hire training and drives the development of new hires within the Proposal Lead team
  • Collaboratively works with direct reports to set meaningful performance objectives
  • Clarifies responsibilities and expectations and holds employees accountable
  • Participates in and conducts timely HR-related processes
  • Provides timely constructive feedback that is clear and direct
  • Uses appropriate methods and flexible interpersonal style and coaching to develop one’s own capabilities and the capabilities of others
  • Establishes an effective, professional, and positive relationship with coworkers and partners
  • Provides guidance on how to strengthen one’s own knowledge, skills, and abilities to improve personal and organizational performance
  • Recognizes and reinforces developmental efforts, progress, and improvements

Physical Requirements

Frequent sitting, standing, walking, reading, and use of computer monitor. Occasional stooping, kneeling, crouching, bending, carrying, and grasping. Compliant with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.