Manager - Regulatory Affairs - Therapeutic Area - Lexington, United States - Novo Nordisk

Novo Nordisk
Novo Nordisk
Verified Company
Lexington, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

About the Department


Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation.

The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development.

Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas.

We recognize that improving human health starts here and that patients rely on us.

Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources,and stability, uniting the best of both worlds to develop new medicines for patients.


The Position
Manage and oversee all assigned projects/products/processes.

Assist the Director/Associate Director in assuring Novo Nordisk compliance with internal SOPs and global regulations, including compilation and submission of any required documents to regulatory agencies.


Relationships
Report to a Director of Regulatory Affairs.

Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs and other local and headquarter departments to accomplish company goals.

External relationships may include interactions with personnel from FDA or other regulatory agencies regarding assigned projects and roles.


Essential Functions

  • Create and maintain product/project database to record history of questions asked / responses received during agency interactions
  • Maintain uptodate knowledge of laws, regulations and guidance documents as they relate to pharmaceuticals
  • Manages development projects or portions of projects
  • May act as FDA liaison for routine contacts and handle finalization of routine correspondence
  • Serve as a key member of the matrix regulatory team including generation of meeting agenda and minutes
  • Provide oversight of annual reports
  • Participate in project team meetings as assigned
  • Contribute to the generation and review of regulatory strategy documents
  • Research and analyze the evolving competitive and regulatory landscapes to maintain current knowledge
  • Work with Global Regulatory Lead and team to draft meeting requests and supporting briefing packages for agency meetings
  • Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, premeeting package, and other regulatory positioning documents to assist Global Regulatory Leads

Physical Requirements
0-10% overnight travel required.


Qualifications

  • A Bachelor's degree required with a minimum of 4 years of regulatory affairs experience; or a Master's degree with a minimum of 3 years of regulatory affairs experience; or a Doctorate degree with a minimum of 1 year of regulatory affairs experience within the pharmaceutical/biotech industry. Life Science and advanced degree preferred.
  • Advanced knowledge of pertinent regulations and guidance documents
  • Detail & deadline oriented; well organized
  • Excellent verbal & written communication skills
  • Experience leading projects in specific regulatory area preferred
  • Good interpersonal skills; ability to interact with staff on all levels
  • Strong organizational and demonstrated problemsolving capabilities
  • Ability to thrive in a busy environment and maintain a positive attitude under pressure
  • Knowledge of rare disease and/or expedited regulatory pathways beneficial
  • Works independently with mínimal supervision
  • Previous hands on experience with compilation and filing of INDs/NDAs/Amendments/Supplements desired
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.

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