We have other current jobs related to this field that you can find below

  • Regulatory Affairs Lead

    16 hours ago

    London, Greater London, United Kingdom Austin Vita Full time

    Senior Regulatory Affairs SpecialistAustin Vita seeks a highly skilled Senior Regulatory Affairs Specialist to lead our Regulatory Affairs Team.Ensure medical device regulatory compliance with national and international legislation for projects, products, and new market clearance.Manage specific regulatory objectives to meet the company's Strategic Plan and...

  • Public Affairs Specialist

    3 days ago

    London, Greater London, United Kingdom Rud Pedersen Public Affairs Full time

    About UsRud Pedersen Public Affairs is a leading public affairs and strategic communications group with a strong presence in Europe. We are a dynamic and collaborative team that is passionate about building a high-quality challenger brand in the London market.Job SummaryWe are seeking a highly motivated and experienced Public Affairs Specialist to join our...

  • Lead Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom MSI Group Ltd Full time

    MSI Group Ltd is on the lookout for an accomplished Regulatory Affairs Specialist in the medical devices sector to enhance their distinguished Consumer Healthcare division with a flexible working arrangement.Key Responsibilities:Formulate regulatory pathways for both EMEA and international markets.Provide regulatory guidance to product development...

  • Compliance and Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom Goodman Masson Full time

    Position Overview:We are seeking a dedicated professional to join our team as a Compliance and Regulatory Affairs Specialist. This role is pivotal in ensuring our organization adheres to the ever-evolving regulatory landscape.Key Responsibilities:Engage with Compliance and various departments to perform thorough assessments of regulatory...

  • Senior Specialist in Regulatory Affairs

    2 weeks ago

    London, Greater London, United Kingdom MSI Group Ltd Full time

    MSI Group Ltd is on the lookout for an experienced professional in the field of medical devices to enhance their distinguished Consumer Healthcare division on a flexible working arrangement.Key Responsibilities:Formulate regulatory approaches for both EMEA and international markets.Provide regulatory guidance to product development teams.Oversee regulatory...

  • Global Head of Regulatory Affairs

    2 weeks ago

    London, Greater London, United Kingdom Pharma Partners Recruitment Ltd Full time

    Position OverviewJob Title: Global Head of Regulatory AffairsPharma Partners Recruitment Ltd is collaborating with a pioneering global pharmaceutical organization in search of a Global Head of Regulatory Affairs. This pivotal role involves providing strategic direction and oversight to the Regulatory Affairs division, focusing on the formulation and...

  • Lead Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom CY Partners Full time

    Opportunity Overview: We are seeking a highly skilled individual to take on the role of Lead Regulatory Affairs Specialist at CY Partners. This position offers a hybrid working model, allowing for flexibility in your work environment. About the Role: In this pivotal role, you will contribute to the development of an innovative Product Lifecycle Management...

  • Regulatory Affairs Manager

    2 months ago

    London, Greater London, United Kingdom The George Institute for Global Health Full time

    Position Description REPORTING RELATIONSHIP: Director Global Project OperationsCAREER STEP: Specialist (Projects)EMPLOYMENT DURATION: Per contract (2-3 years)START DATE: ASAP About The George Institute for Global HealthThe George Institute for Global Health was established in 1999 with a mission to improve the health of millions of people worldwide,...

  • Regulatory Compliance Specialist

    2 weeks ago

    London, Greater London, United Kingdom Cancer Research UK Full time £38,000 - £44,000

    Position: Regulatory Compliance Specialist Reports to: Senior Regulatory Compliance Manager (Team Lead) Contract: Fixed-term contract Working Hours: Full-time, 35 hours per week (flexible working arrangements considered) Home-based with occasional travel to the head office or office location (high flexibility expected, with a minimum of 1 day per week in...

  • Associate Director, Regulatory Affairs

    2 weeks ago

    London, Greater London, United Kingdom Cpl Full time

    Job Title: Associate Director, Regulatory Affairs - Medical DevicesJob Type: Full Time, Permanent Position Location: Greater London, UK and some EU locations Remuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specialises in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to...

  • Regulatory Affairs Director

    3 days ago

    London, Greater London, United Kingdom Holland and Barrett Full time

    About the RoleHolland & Barrett is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for developing and implementing regulatory strategies that align with our business goals.Key ResponsibilitiesRegulatory Strategy Development: Collaborate with cross-functional teams to design...

  • Gas Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom Shell Full time

    Position Title:Regulatory Affairs AdvisorLocation:London, United KingdomAbout Shell UKShell is a prominent global energy corporation focused on addressing the increasing demand for sustainable energy solutions. Operating in over 70 countries, Shell is committed to achieving net zero emissions by 2050. This ambitious objective entails tackling emissions...

  • Gas Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom Shell Full time

    Position Title:Regulatory Affairs AdvisorLocation:London, United KingdomAbout Shell UKShell is a prominent global energy corporation dedicated to addressing the increasing demand for sustainable energy solutions. With a presence in over 70 nations, Shell is focused on achieving net zero emissions by 2050. This ambitious target necessitates tackling emissions...

  • Gas Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom Shell Full time

    Position OverviewWe invite you to leverage your expertise and eagerness to understand gas markets and the regulatory landscape surrounding biomethane certificates. Join Shell Energy Europe and Africa (SEA), a dynamic organization dedicated to advancing Shell's vision for the Energy Transition. This role is ideal for individuals who excel in a fast-paced...

  • Regulatory Affairs Director

    3 days ago

    London, Greater London, United Kingdom Pharmiweb Full time

    Job DescriptionJob Title: Head of Regulatory AffairsCompany: PharmiwebLocation: UKJob Type: Full-timeIndustry: PharmaceuticalJob Description:Regulatory Strategy Development:Develop and implement regulatory strategies to expedite the approval process for investigational products.Provide expert guidance on regulatory requirements and compliance to support...

  • Senior Counsel

    2 weeks ago

    London, Greater London, United Kingdom Project People Full time

    SENIOR COUNSEL - COMPETITION AND REGULATORY AFFAIRS - HYBRIDPosition OverviewAs a Senior Counsel specializing in Competition and Regulatory Affairs, you will play a pivotal role in navigating the complexities of a highly regulated market. This position requires a professional who is either UK, EU, or dual qualified and is adept at providing strategic legal...

  • Gas Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom Shell Full time

    Position Title:Regulatory Affairs AdvisorLocation:London, United KingdomAbout Shell UKShell is a prominent global energy corporation focused on fulfilling the increasing demand for sustainable energy solutions. Operating in over 70 countries, Shell is committed to achieving net zero emissions by 2050. This ambitious objective entails tackling emissions...

  • Regulatory Affairs Manager

    2 weeks ago

    London, Greater London, United Kingdom MEMBERSHIP BESPOKE Full time £55,000 - £65,000

    Regulatory Affairs Manager Leading Trade Association – Financial Sector Competitive Salary £55,000-£65,000 based on experience with comprehensive benefits including 26 days of annual leave, Pension Plan, Health Coverage, and Life Insurance at 4 times the annual salary. Permanent, Full Time Our client, a prominent trade association within the...

  • Senior Vice President, Insurance Regulatory Affairs

    2 weeks ago

    London, Greater London, United Kingdom Moody's Investors Service Full time

    Experience Level: Experienced Hire Categories: Corporate Services Location(s): Global At Moody's Investors Service, we bring together exceptional talent to transform current challenges into future possibilities. Our commitment to fostering an inclusive atmosphere allows everyone to express their authentic selves, share innovative ideas, and engage in...

  • Regulatory Affairs Manager

    2 weeks ago

    London, Greater London, United Kingdom MEMBERSHIP BESPOKE Full time £55,000 - £65,000

    Regulatory Affairs Manager Please ensure you review the following information thoroughly before proceeding with your application. Leading Trade Association – Financial Sector Hybrid Working Model Competitive Salary Range £55,000-£65,000 based on experience, along with comprehensive benefits including 26 days of annual leave, Pension Plan,...

Senior Specialist Regulatory Affairs

2 months ago

London, Greater London, United Kingdom MSD Full time

Job Description

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.

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.

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.

Responsibilities:

  • Developing regulatory strategy and contributing to regulatory filing activities and documentation for paediatric submission, new marketing authorisation applications and product launches.
  • Life-cycle maintenance of all aspects of the marketing authorisation's registered particulars.
  • Liaising and negotiating with the Medicines and Healthcare products Regulatory Agency
  • Implementation and communication of marketing authorisation's 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.
  • Advocates for therapeutic areas/local positions on regulatory issues and trends internally and externally contributing to a broader policy platform.
  • 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.
  • Maintaining a positive relationship with internal and external regulatory contacts.
  • Utilising 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.

Qualifications and Experience:

  • BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject.
  • 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 and 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

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.

THE COMPANY...

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 ...

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 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R223457