Global Regulatory Affairs Oncology, Strategist (all genders)
Your role : The Strategist for Global Regulatory Affairs (GRA) Oncology develops and prepares regulatory strategies for projects. It manages submission and approval of applications for clinical trials (WW) and marketing applications, full submissions and variations in 3 ICH regions. In addition, the role represents the company in external forums and in co-development joint committees. Internally the role works as representative for GRA in Global Project Teams. The role manages the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation. As strategist you will manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes. The role manages in addition the Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs and CTD (development and registration status) and leads a GRA sub-team.
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
Job Requisition ID: 207554
Career Level: D - Professional (4-9 years)
Working time model: full-time
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, Healthcare, Strategy