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Associate Director, Global Regulatory Affairs Strategy, Oncology

Your Role

In the Global Regulatory Affairs group you will be actively involved in the development and life-cycle management of medicinal products thereby contributing to appropriateness of the drug development path as well as to compliance with applicable pharmaceutical legislation.

 

As the Associate Director you will function as a Regional lead and Health Authority liaison, responsible for preparation and execution of regional regulatory activities and submissions, and to contribute to the regulatory strategies for supporting clinical trials, marketing applications or other related regulatory submissions (orphan designation, annual report, pediatric plans and DSUR etc.)

 

  • Manage Health Authority communications including coordination of the preparation of all regulatory documents at different regulatory milestones;  coordination of meeting activities including rehearsals and minutes (under supervision)
  • Contribute to development and evaluation of regulatory strategies for projects (under supervision)
  • Review and provide regulatory comments to quality-, safety- and efficacy or labeling related documents (e.g. protocols, reports) to be included in a regulatory submission (e.g. Clinical Trial Applications, IND, Scientific Advice, HA interactions, Answers to Authorities, PIP/PSP, ODD, DSUR…)
  • Contribute to the development of risk assessment pertaining to the quality-, safety- and efficacy documentation/data of investigational medicinal products related applications.

Who You Are

  • Bachelors degree, higher degree preferable (Pharm.D., MSc, PhD, MBA)
  • Minimum of 5 years’ relevant regulatory experience
  • Experience with preparation and writing regulatory documentation to support agency interactions
  • Experience in IND / CTA / eCTD requirements
  • Knowledge of regulatory affairs applicable to location of residence (US or EU)
  • Experience with maintenance of regulatory authorizations
  • Experience with supporting a project with development activities
  • Excellent written and spoken communication skills
  • Good interpersonal skills
  • Attention to detail
  • Ability to work in teams
  • Strong organizational and planning skills

 

 

 

Job Requisition ID:  190085
Location:  Billerica
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

Job Segment: Oncology, Medical, Manager, Pharmaceutical, Healthcare, Management, Strategy, Science

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