Associate Director Global Regulatory Affairs CMC Regulatory Intelligence _US

Posted 17 Jul 2019

Billerica, Massachusetts - United States

Req Id 194530

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 Serono is a business of Merck KGaA, Darmstadt, Germany.


The Associate Director, Global Regulatory Affairs CMC Regulatory Intelligence is responsible for helping the EMD Serono team to acquire, apply knowledge, and leverage skills to fulfill best patient expectations while keeping control of the US pharmaceutical Regulated Environment.

 

Your Role:

As Associate Director GRA CMC Regulatory Intelligence, you will be responsible for

 Drive interactions aiming at improvements of global CMC regulations and regulatory knowledge adoption with a specific focus on US

  • Coordinate and develop a consolidated company position.
  • Lead specific Regulatory CMC Intelligence Committee/Community (e.g QRAC, ATO, Trade association reps, pharmacopoeia…)
  • Enable commenting, interpretation, and risk analysis of CMC guidelines in collaboration with Regulatory Affairs' and other functions’ stakeholders
  • Perform surveillance on global CMC related regulatory requirements

CMC regulatory intelligence activities with a focus on implementation of global Health Authority requirements with priority on US

  • Develop knowledge management strategies to drive implementation of evolving regulatory requirements
  • Build Regulatory CMC knowledge foundation in close collaboration with CMC related departments and functions, e.g. update of country requirement database, author guides, template
  • Provide CMC regulatory advice and develop position papers to support the product development activities as well as CMC regulatory strategies
  • Develop and deliver internal and external training on CMC regulatory topics

Develop Strategic interactions and collaborative partnerships with Heath Authorities and US Trade Associations

  • Represent the company in industry associations (main trade associations), expert groups and public conferences, workshops, congresses

 

Who You Are:

Minimum Qualifications

  • You have a MSc Degree in a Life Science or related discipline
  • Minimum 7 years’ experience with strategic and business critical responsibilities related to US CMC regulatory and/or related to CMC regulatory Intelligence in industry.
  • In-depth knowledge of global pharmaceutical legislation and CMC regulatory requirements
  • Awareness of regulatory affairs contribution to Pharma business
  • Experience in preparation, review and strategy of CMC regulatory documentation during clinical development and life-cycle management activities in at least two regions (e.g. Europe, International would be an asset)
  • Practical experience in one of the following area for biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management
  • Excellent written and spoken communication skills in English
  • Strong interpersonal skills of respect, integrity, and transparency with an open and flexible mindset
  • Ability to think strategically and to collaborate across functions and departments
  • Solution- oriented  to find constructive solutions and unlock opportunities

Preferred Qualifications

  • You have a PhD Degree in a Life Science or related discipline
  • Minimum 10 years’ experience with strategic and business critical responsibilities related to US CMC regulatory and/or related to CMC regulatory Intelligence in industry including as assessor in governmental institution.
  • Knowledge of other European languages is an asset such as German
  • Ability to work in teams
  • Organizational skills
  • Networking skills
  • Educational and presentation 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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