Associate Director, Global Regulatory Affairs Strategy, Oncology

Posté 29 sept. 2020

Billerica, Massachusetts - United States

Demander un identifiant 210829

Détails

A career with EMD Serono is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.


In the Global Regulatory Affairs, Oncology 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.

 

Your Role

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

Minimum Qualifications:

  • Bachelors degree
  • Minimum of 5 years’ relevant regulatory experience in Oncology 
  • Experience with preparation and writing regulatory documentation to support agency interactions (FDA)
  • Experience in IND / CTA / eCTD requirements
  • Knowledge of regulatory affairs applicable to location of residence (US and EU)
  • Experience with maintenance of regulatory authorizations
  • Experience with supporting a project with development activities
  • Excellent written and spoken communication skills

Preferred Qualifications 

  •  Advanced degree preferable (Pharm.D., MSc, PhD, MBA)
  • Good interpersonal skills
  • Attention to detail
  • Ability to work in teams
  • Strong organizational and planning skills

 


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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.

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