Associate Director, Regulatory Affairs Europe

Do you want to be part of our Vaccines, Infectious Diseases and General Medicine Division, helping to save and improve lives?

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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 partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. We have a new, exciting opportunity for an Associate Director Regulatory Affairs Europe role to be based in London (UK), Brussels (BE) or Oss (NL).

The purpose of the position

The person in this role will coordinate regulatory activities in the EU, UK, Switzerland and non-EU Balkan countries, with minimal guidance of the Executive Director (or delegate).

The department

Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety (GRACS). In GRACS we are always striving for operational excellence. Our group covers a wide range of activities related to getting products on the market and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients. Our current portfolio in Vaccines, Infectious diseases and General Medicine is creating countless opportunities and challenges for the team. Activities are numerous and the dedication and commitment of the team is very rewarding. Our portfolio provides the chance to learn something new every day!

Primary activities:

• Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of post-approval submissions in the EU, UK, Switzerland and non-EU Balkan countries.

• For assigned development and/or marketed products, lead cross-functional Teams

• Work with project teams to develop and implement regulatory strategies (including scientific advices and paediatric investigational plans, or orphan designation), identify regulatory risks, and enable earliest possible approval. Ensure regulatory strategies are aligned with project teams and business objectives and deliverables.

• Accountable for Agency interactions to ensure a seamless submission, assessment and quick approval of CTAs under the new EU Clinical Trial Regulation, in liaison with the Country RA teams in the region, and other internal stakeholders.

• Serve as principal regulatory contact with regulatory agencies and Country RA teams

• Serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams. Develop and implement effective processes to meet business objectives and ensure appropriate compliance with regulatory requirements

Your profile

• M.D., Ph.D. or Master degree with at least 3-4 years of experience in clinical research or regulatory affairs is required. Individuals who have demonstrated competence in biomedical research gained through appropriate experience of 1-2 years and who possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry would be considered.

• Advanced, interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment; able to manage complex projects by exercising independent decision making and analytical thinking skills.

• Knowledge/experience of EU regulations, guidelines and regulatory processes for NCEs and product life cycle maintenance; ability to work in cross-functional and international environment.

• Detail- and goal-oriented, quality conscientious, and customer-focused.

• Ability to adhere to strict project timelines; strong team player; good judgment and problem-solving skills, with ability to identify, analyze, and resolve problems in a timely manner.

• Fluent written and spoken English is required

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to 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 a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are committed to Flexible Working, and whatever role you are in there will be options to balance your needs and the needs of the business. This could be a hybrid way of working with some time on site and some remotely or flexibility around the hours you work each day. Of course in some parts of the business, certain roles do require a fully on-site presence, whilst others can be performed entirely remotely. Please speak to us during your application process to discuss further.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R138473