Senior Representative Regulatory Affairs 323853
Senior Representative Regulatory Affairs 323853
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Salary Not Disclosed
1 Vacancy
Job Description
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 lifechanging 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 stateoftheart 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:
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including14 paid holidays
- Health Insurance Dental Insurance Vision Insurance effective day one
- Guaranteed 8 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordiskmarketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- 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 organizations 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 crossfunctional 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:
- Bachelors Degree required
- Masters Degree preferred
- RAPS Certificate preferred
- 5 8 years of relevant experience
- 6 years GMP experience preferred
- Must be able to read and understand Englishwritten 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 problemsolving skills and mathematical abilities
- Desire to go above and beyond and not only meet but exceed client expectations
- Behavioral Requirements:
- Resultsoriented and datadriven
- Selfmotivated and able to lead follow up and drive document generation to completion with manager support as needed
- Detailoriented with strong ability to multitask within a fastpaced 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 HRrelated processes
- Provides timely constructive feedback that is clear and direct
- Uses appropriate methods and flexible interpersonal style and coaching to develop ones own capabilities and the capabilities of others
- Establishes an effective professional and positive relationship with coworkers and partners
- Provides guidance on how to strengthen ones 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 were 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. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Required Experience:
Senior IC
Employment Type
Full Time
