Global Regulatory Affairs is a dynamic team that is 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 / regulation. The purpose of the regulatory affairs support is to assist the global regulatory lead and/or the Regional lead in preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical trials, marketing applications or other related regulatory submissions (orphan designation, annual report, pediatric plans and DSUR etc.)
- Manage the regulatory submission including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
- Manage of the regulatory agency interactions, document preparation, coordination rehearsals and minutes (under supervision of a Therapeutic Area Head or Regulatory Strategist)
- Contribute development and evaluation of regulatory strategies for projects (under supervision of the Regulatory Strategist)
- 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.
- Bachelor’s degree in Life Science or related discipline.
- Excellent spoken and written English
- Minimum of 5 years’ industry experience of which at least 3 years’ US regulatory experience
- Experience with preparation and writing regulatory documentation to support agency interactions
- Experience in IND / CTA / eCTD requirements
- Knowledge of international regulatory affairs
- Advanced Degree (Pharm.D., MSc, PhD, MBA)
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.