Global Regulatory Strategist, Manager

Posted 08 Jul 2019

Billerica, Massachusetts - United States

Req Id 193960

Details

A career with EMD Serono is an ongoing journey of discovery: our 52,000 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 Performance Materials is a business of Merck KGaA, Darmstadt, Germany.


Global Regulatory Affairs 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 Global Regulatory Strategist 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 drug designation (ODD), breakthrough designation (BTD) and IND/NDA annual report, pediatric study plans (PSP), DSUR, PBRER, labeling documents, etc).

 

Your Role:

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 drug designation (ODD), breakthrough designation (BTD) and IND/NDA annual report, pediatric study plans (PSP), DSUR, PBRER, labeling documents, etc).

 

  • Manage the regulatory submission process from initiation to approval including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
  • Manage of the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a TA Head or Regulatory Lead)
  • Contribute to development and evaluation of regulatory strategies for projects (under supervision of the Regulatory Lead)
  • 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/NDA, Scientific Advice, HA interactions, Answers to Health Authority Questions, PIP/PSP/PPSR, ODD, BTD, Sakigake, briefing book, DSUR…)
  • Contribute to the development of risk assessment pertaining to the quality-, safety- and efficacy documentation/data of investigational medicinal products related applications.
  • Research regulatory precedents on prior approvals, clinical endpoints, compare labels of competitors
  • Liaises with Regulatory Operations to develop submission content plans

 

Who You Are:

 

  • Bachelors Degree in Life Science or related discipline
  • Minimum of 4 years’ regulatory experience
  • Excellent spoken and written English
  • Experience with regulatory submission procedures and regulations, preparation and writing regulatory documentation for regulatory maintenance activities and to support agency interactions
  • Experience in eCTD requirements in compiling IND / CTA in US and/or RoW regions
  • Experience with supporting a project with development activities in at least one region

 

Preferred:

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

 


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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