Associate Director - Global Regulatory Lead 324580
Associate Director - Global Regulatory Lead 324580
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Salary Not Disclosed
1 Vacancy
Job Description
About the Department
Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington MA and Plainsboro NJ. We support programs from early research through latestage clinical development. We are building for the future creating a distinct R&D community based on collaboration partnerships and cuttingedge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development 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. We recognize that improving human health starts here and that patients rely on us. Were changing lives for a living. Are you ready to make a difference
The Position
We are seeking a collaborative and sciencedriven global regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for high impact projects while working with decisionmakers across multiple functional areas.
Relationships
You will report to the Senior Director Regulatory Affairs (based in Lexington).
Essential Functions
- Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals advise on development strategies and deliver on associated regulatory activities
- Lead the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and highquality regulatory deliverables to the GPTs
- Lead health authority interactions including leading team through creation of briefing materials and meeting preparation
- Lead and/or support global filing activities for submissions
- Present regulatory strategies including communication of regulatory risks and associated mitigation plans to management and other internal stakeholders
- Perform regulatory review of all clinical and nonclinical documents for submissions e.g. clinical protocols and study reports preclinical reports investigator brochures application summary documents etc.
- Research and analyze the evolving competitive and regulatory landscapes to maintain current knowledge
- Effectively managing timelines while working in a fastpaced and dynamic environment across both time zones and cultures
Physical Requirements
010 overnight travel required. Ability to lift 010 lbs.
Qualifications
- A Bachelors required/Advance degree preferred
- Minimum of 8 years total pharmaceutical/related industry experience in drug development required
- Demonstrated knowledge of global regulatory requirements for and biologics
- Proven ability to develop robust regulatory strategies required
- Experience interacting directly with regulatory authorities on an international scale
- Experience preparing teams for and leading meetings with regulatory agencies including the FDA
- Experience with rare disease drug development innovative trial design and/or expedited regulatory pathways highly desired
- Experience in setting direction for leading and motivating a team to work for joint objectives
- Excellent verbal and written communication skills
- Strong organizational and demonstrated problemsolving capabilities
- Ability to thrive in a busy environment and maintain a positive attitude under pressure
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:
Exec
Employment Type
Full Time
