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Strategist Global Regulatory Oncology (all genders)

Your role:

 

Prepare global regulatory strategies for projects. Manage submission and approval of applications for clinical trials (WW) and registrations (WW), full submissions and variations in 3 ICH regions. Represent the company in external forum, in co-development joint committees, and GRA in Global Project Teams. Lead GRA sub-team depending on development status of projects. Manage the regulatory submission process from pre-submission health authority interactions through to approval including management and coordination of the preparation of all regulatory documentation. Manage the regulatory agency interactions, document preparation, co-ordination rehearsals, minutes, and ensure the impact for the project is transferred to the Project Team. Review of clinical study protocols, study reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs and CTD (development and registration status). Be open for new innovative regulatory pathways to accelerate the overall development.

 

Who you are

 

  • Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, Degree in pharmacy or medicine)
  • Minimum of 8 years’ industry experience of which at least 6 years’ regulatory experience
  • Experience in preparation and submission of a full submission/or large variation/supplement in at least one ICH region through to authorization
  • Experience with regulatory agency interactions and preparation of documentation to support interactions
  • Experience in NCE and NBE drug development
  • Excellent spoken and written English
  • Team collaboration is a key competence
Job Requisition ID:  190806
Location:  Darmstadt
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.


Job Segment: Oncology, Medical, Strategist, Pharmacy, Medical Research, Healthcare, Strategy

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