Job Detail

JOB DESCRIPTION

Job Description

Do you have an M.D., Pharm.D., Ph.D or Master’s degree in life science and at least eight years of experience in regulatory affairs or related discipline? Do you have previous regulatory experience or a related discipline within Infectious Diseases and /or Vaccines and strong people management skills? Do you have demonstrated ability to translate deep knowledge and experience in the global/ regional/ local regulatory landscape to advise on and drive the company’s cross-functional regulatory strategy?

For our Regulatory Affairs – Europe (RAE) Organisation we are hiring a:

Senior Principle Scientist, Regulatory Liaison Europe – Vaccines & Infectious Diseases

This role could be based in either Brussels, Oss or Haarlem (The Netherlands), London or Zurich.

Welcome to our team

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.

Reporting into the Executive Director, Vaccines and Infectious Diseases, Regulatory Affairs Europe, you will be responsible for developing the EU product regulatory strategy for vaccines/ biologicals in this therapeutic area, in order to optimize the label and obtain shortest time to approval by regulatory agencies. You will oversee the maintenance of preventive vaccines/ biologicals in this therapeutic area and you will be responsible for compliance in the EU region for the assigned vaccines/ biologicals. You will interact independently with the company’s subsidiaries and/ or Regulatory Agencies in the region with regard to regulatory strategy/ registration requirements for the vaccines/ biologicals assigned. Next to that you will be responsible for regulatory review and final approval of all submissions and associated documentation for the assigned vaccines/ biologicals. The projects assigned may be complex, broad in scope, with more than one indication or formulation or have an external business partner.

In this role you would lead  a team of Regulatory Liaisons and provide advice to your staff on regulatory and therapeutic area level.

Primary responsibilities

• Effectively manage the people in your team and for the assigned projects;


• Develop EU product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies, for multiple indications;


• Develop product regulatory strategy for non-EU countries in the RAE region, such as Switzerland and non-EU CES, to optimize the label and obtain shortest time approval in these markets;


• Interact independently with the subsidiaries and the regulatory agencies in the region on regulatory strategy/ registration requirements for the projects and therapeutic area assigned;


• Oversee the maintenance of all vaccines/ biologicals in your therapeutic area and responsible for regulatory compliance of these products in the EU region;


• Responsible for all regulatory procedures in the region for the assigned projects and therapeutic area, including but not limited to PIP applications, local and regional Scientific Advice, mutual recognition procedures, decentralized procedures, centralized procedures and national procedures (as far as in scope);


• May conduct due diligence licensing candidate review;


• Responsible for regulatory review and final approval of all submissions and associated documentation for the assigned vaccines/ biologicals;


• Provide support to the RAE subsidiary personnel on subjects related to the projects or therapeutic area assigned;


• Provide EU regional expertise to the worldwide regulatory franchise team, the product development teams and the Vaccines franchise;


• Be a recognized, internal expert (SME) for one or more aspects of regulatory policy and recognized as a scientific expert in one or more therapeutic areas.

Your profile

• M.D., Pharm.D.,  Ph.D or Master’s degree in life science;


• At least eight years of experience in regulatory affairs or related discipline;


• Previous experience within Vaccines is required, experience within Infectious Diseases is a strong plus;


• Strong people management skills are a pre-requisite, previous experience in a people management position is an asset;


• Demonstrated ability to translate deep knowledge and experience in the global/ regional/ local regulatory landscape to advise on and drive the company’s  cross-functional regulatory strategy;


• Subject matter expert related to regulatory/ risk communications and submissions, and able to advise on effective data and presentation approaches;


• Able to effectively influence and negotiate with regulatory agencies related to the company’s submissions, clinical risk management and pharmacovigilance strategies to achieve positive regulatory outcomes;


• Able to respond to complex inquiries, specific to the disease environment across different regions and key markets, and able to lead external scientific advisor interactions;


• Able to demonstrate advanced knowledge of emerging trends and treatment practices by contributing to industry publications and interacting with internal expert within a disease and therapeutic area;


• Applies advanced knowledge of translational medicine to advise study teams on protocol design and research feasibility factors;


• Excellent interpersonal, written and verbal communication skills both internal and with regulatory health authorities;


• Excellent oral and written communication skills in English.

We offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive and the summary below will give you an idea of what you can expect.

• A competitive salary;


• Vacation days;


• Annual Incentive Plan (bonus);


• Long term Incentive Plan (shares):


• An excellent pension;


• Additional benefits are location dependent.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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 for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R41079