Director, Global Regulatory Affairs CMC

Posted 02 Jul 2019

Billerica, Massachusetts - United States

Req Id 193266

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.


Your role:

 

Accountable for strategic oversight of the assigned GRA-CMC group of experts, through inspirational leadership and expertise.  This role reports directly to the Head of GRA-CMC and collaborates and partners with other functions and other pharmaceutical companies in the context of Trade and Regulatory Associations. 

 

CMC Regulatory strategy and Health Authority interactions:
• Endorse the global CMC-part of the regulatory strategy (RSD) for the products under his/her responsibility. This encompasses  risk assessment, strategic support and advice.
• Provide support to the GRL/MPL during Health Authority interactions on CMC issues

 

Management of CMC Regulatory activities and people
• Development of a best in class, fully integrated global regulatory CMC group, providing leadership with a focus on behaviors that cultivate collaboration, innovation and results-orientation.
• Setting GRA-CMC objectives at a group level in alignment with the relevant stakeholders
• Collaboration with stakeholders on a management level, e.g., GRA and GMS leadership teams, supervisory committees of partners, regulatory authority senior managers
• GRA-CMC support to functions and projects
• Endorse the compilation of the country specific CMC regulatory requirements of proposed regulatory  submissions in the CMC area
 
Regulatory intelligence and knowledge management
• Maintain knowledge of regulatory environment within the CMC regulatory area current;
• Review draft and newly released laws and guidance on behalf of the Company

 

Global Regulatory Affairs CMC coordination
• Budget management at a group level
• Due Diligence (Upon request)

 

This role spans oversight of research and development projects as well as life cycle management of the approved product portfolio with accountability for the overall Global Regulatory CMC strategy and ensuring consistency with the Global Regulatory and portfolio strategy

 

Who you are:

 

Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

Minimum of 10 years of pharmaceutical industry experience, with at least 5 years of global CMC regulatory experience

Strong people management and leadership skills at a group level with a focus on building consensus through negotiation and best practices
Collaborate across multiple functions and within the department in Leadership teams

Practical experience in one of the following area for biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management
In-depth knowledge of global pharmaceutical legislation
Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German)
Good interpersonal skills and flexible mindset

Ability to think strategically
Ability to work in teams
Awareness of regulatory affairs contribution to Pharma business
Excellent managerial skills Good 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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