Senior Specialist, Regulatory Affairs - UK
- Experience Level
- Experienced (non-manager)
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” then 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, organised 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.
An exciting opportunity has arisen in the UK Regulatory Affairs Department, for a Senior Specialist to join our expanding team.
The team manages a broad portfolio of prescription medicines for the UK, largely across the vaccine, oncology and infectious disease therapeutic areas and this role is accountable for undertaking a variety of regulatory activities across a range of products for the UK market including:
Developing regulatory strategy and contributing to regulatory filing activities and documentation for new marketing authorisation (MA) applications and product launches.
Life-cycle maintenance of all aspects of the MAs registered particulars.
Liaising and negotiating with the MHRA.
Implementation and communication of MA changes across stakeholder groups. Ensuring all compliance activities are correctly managed.
Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management, and ensure regulatory compliance with legislation and company approval systems.
Developing and maintaining a sound knowledge of European and UK regulatory legislation and guidelines to provide advice and expertise internally for matters related to our products.
Representation of regulatory affairs at cross functional meetings including product acquisitions and ad-hoc product issues.
Utilizing and maintaining company compliance systems in relation to product portfolio and meeting compliance expectations.
Working as a strong member of the UK regulatory team, contributing to departmental meetings, ad-hoc projects and issues.
BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject.
For the Specialist level - some exposure to a regulatory affairs department would be an advantage. Other experience within the pharmaceutical industry may be considered.
For the senior specialist level - solid and deep knowledge of Regulatory affairs through working in a regulatory affairs related role in the pharmaceutical industry. comprehension of the fast evolving EU/UK regulatory procedures and EU and UK Medicines Legislation. Exposure to regulatory submissions and working with a Regulatory Authority would be a strong advantage.
Excellent verbal and written communication and interactive skills.
Work on own initiative and take responsibility for managing the day to day regulatory activities for a portfolio of products.
Work effectively within the Regulatory Affairs team and with other stakeholders to deliver on Company Objectives and Goals.
Able to multitask and manage conflicting priorities with sound time-management skills.
Able to demonstrate a genuine interest and knowledge of the regulatory environment and a desire to succeed in a regulatory affairs role in the pharmaceutical industry.
Ability to identify compliance risks and escalate when necessary
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.
Our presence in the UK goes back a long way. For over 80 years, we’ve been researching, developing and supplying new medicines and vaccines that prevent and treat diseases that occur at every stage of life. Today we're one of the top five biopharmaceutical companies in the UK and employ over 2,000 people across five sites in Hertfordshire, Northumberland, Buckinghamshire, Edinburgh and London. We are officially certified by the Top Employer Institute and been awarded the exclusive Top Employer United Kingdom Certification.
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 …
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.
We are officially certified by the Top Employer Institute and been awarded the exclusive Top Employer United Kingdom Certification for the second year running.
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.