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Director, Regulatory Affairs Europe

Employer
MSD
Location
Europe
Salary
Competitive
Start date
30 Sep 2022
Closing date
30 Oct 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive
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Job Details

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

 

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Our Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety  organisation.  We cover a wide range of activities related to getting products and keeping them on the market. Our large portfolio in Vaccines, Infectious Diseases and General Medicine includes medicinal products at all stages of the marketing authorisation’s life cycle and span a number of therapeutic areas. It provides the chance to learn something new every day!

 Activities are numerous and the dedication and commitment of the team is very rewarding.

 

We have a new, exciting opportunity for a Director, Regulatory Affairs Europe to be based in London, Kings Cross. We are also flexible for other locations; Brussels, Belgium and Oss in the Netherlands.

 

In this role you will coordinate regulatory activities and strategies in the EU, UK, Switzerland, Southern and Eastern European countries. This is a role suitable to a regulatory expert with sound scientific knowledge who will manage products at different stages of the regulatory life-cycle, including vaccines.

 

What will you do:

Primary Activities: 

  • Work with project teams to develop and implement regulatory strategies (including scientific advice and paediatric investigational plans, or orphan designation), identify regulatory risks and enable earliest possible approval, in line with business objectives and deliverables. 
  • Coordinate the preparation, review and submission of regulatory dossiers in support of new drug applications, and post-approval submissions in the EEA, UK, Switzerland, Southern and Eastern European countries. 
  • Lead cross-functional teams for assigned development and/or marketed products, including vaccines. 
  • Be accountable for Agency interactions to ensure a seamless submission, assessment and quick approval of Clinical Trial Applications under the new EU Clinical Trial Regulations, in collaboration with the country Regulatory Affairs teams in the region, and other internal stakeholders. 
  • Ensure regulatory milestones for assigned projects are met. 
  • Serve as principal regulatory contact with regulatory agencies and Country Regulatory Affairs teams. 
  • Develop and implement effective processes to meet business objectives and ensures appropriate compliance with regulatory requirements. 
  • Communicate new regulations and standards which may affect our company’s products to other regional colleagues to ensure any broader impact to the organization is also fully understood. 
  • Maintain a thorough knowledge of specific diseases within therapeutic areas assigned, including a detailed understanding of the prevailing attitudes and the practices in each country toward those diseases and their treatment. 

 

Qualifications, Skills & Experience Required  

  • Ph.D. or Masters degree with at least 5 years of experience in clinical research or regulatory affairs is required. 
  • Experience working in vaccines is desirable.
  • Knowledge of EU regulations, guidelines and regulatory processes. 
  • Outstanding interpersonal, written and verbal communications skills.

 

Ways of Working/Competencies:

Win as one team- we act with a company-first mindset inspired by unified goals; communicate, participate and collaborate as one team; winning and losing together.

  • Act with Urgency- We work with speed, rigor, and determination to deliver our medicines and vaccines around the world.
  • Experiment, learn and adapt- We balance our expertise with curiosity, continuous learning, adaptability and a commitment to never give up, whether we succeed or fail.
  • Embrace diversity and inclusion- We create fully diverse teams to deliver our best innovations and cultivate an inclusive environment where everyone is able to contribute their best ideas.
  • Speak up and be open-minded- We voice our opinions, engage in healthy debate and encourage curiosity to improve ideas and decisions to achieve better outcomes.
  • Strong analytical, statistical, and presentation skills.

 

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life. 

 

 

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

 

Company

Imagine getting up in the morning for a job as important as helping save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with other like-minded colleagues to pursue and bring hope to countless people who are battling the most challenging diseases of our time. Our team is always evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Find Us
Website
Telephone
+44-0208-1548000
Location
2 Pancras Square
London
N1C 4AG
GB
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