Senior Regulatory Affairs Associate

3 months ago


London UK, UK, United Kingdom Park Street People Full time

Our client, a global pharmaceutical company, is currently looking for a Senior Regulatory Affairs Associate to join their team in Cambridge or West London (Uxbridge). This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.


Roles are typically remote-by-design but candidates do need to be prepared to travel to their nearest office on occasions for key meetings.


Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory guidance across the EU region and make sure that regulatory deadlines and approvals are achieved (previous EU exposure is preferred).


Other responsibilities include:

  • You will develop, contribute and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
  • Contributing regulatory guidance in order to enhance product development.
  • Ensuring that product development is aligned with the company’s strategy business model as well as global regulatory requirements.
  • Acting as a point of contact between the company and regulatory agencies whilst pertaining important information.


Requirements

  • Previous experience in Regulatory Affairs and Compliance particularly within pharmaceutical industry.
  • You will have a proven background working on CTAs (clinical trial application) and MAAs (marketing authorisation application)
  • Exposure of Regulatory Affairs legislation and procedures
  • Strong communication and interpersonal skills


Pay rate

  • PAYE = £23.70 basic + £3.43 holiday pay (£27.13 total)
  • Umbrella = £31.13 per hour
  • Strong communication and interpersonal skills


Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.



  • UK, UK, United Kingdom Cure Talent Full time

    Cure Talent are delighted to be working with a well-established Medical Device company that supply and distribute innovative Medical Devices. Due to their continued growth and success, we have an exciting opportunity for a Senior Regulatory Affairs Associate to join them in West Yorkshire.As the new Senior Regulatory Affairs Associate, you will be working...


  • UK, UK, United Kingdom VRS Regulatory Full time

    An opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...


  • UK, UK, United Kingdom VRS Regulatory Full time

    Exciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...

  • Senior Consultant

    1 week ago


    UK, UK, United Kingdom VRS Regulatory Full time

    An excellent opportunity to join an ambitious UK based chemical regulatory compliance consultancy. Working closely with the highly experienced and respected Principal Consultant, you will undertake a range of regulatory activities including:Study monitoringWriting up study reportsRisk assessmentsDossier preparationDeveloping regulatory strategyConsortia...


  • London, UK, UK, United Kingdom Park Street People Full time

    A global pharmaceutical company based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products.This is a great opportunity to work with a team who take provide in working...


  • UK, UK, United Kingdom Blackfield Associates Full time

    Our client, a global pharmaceutical company which develops a portfolio of prescription generic and branded pharmaceuticals within the CNS, Neurology and respiratory areas. As Regulatory Affairs Manager, you will:Preparation, submission, and management of variation applications to agreed timelinesManage and submit Renewals and PSURs in line with specified...


  • UK, UK, United Kingdom Cure Talent Full time

    Cure Talent is delighted to be partnered with a global Medical Device company, specialising in emergency medical products, who due to their exceptional continued growth, have an exciting opportunity for Regulatory Affairs Specialist to join them on an initial 6-month Fixed Term Contract. This is a fully remote position and can be based anywhere in the United...


  • UK, UK, United Kingdom Mars Full time

    We have an opportunity for a Senior Scientific and Regulatory Affairs - UK/IRL Market Lead (known internally as - Program Manager SRA (Science & Regulatory Affairs) UK/IRL) to join us at Mars. You will lead a variety of regional regulatory activities related to raw materials, finished products, labelling, claims, packaging and supporting UK/IRL. In this...


  • London,, UK, United Kingdom Warman O'Brien Full time

    Senior Regulatory Affairs ManagerWarman O'Brien are searching for a Senior Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures Generic products in the UK.The role has arisen due to an increase in workload as the team looks to expand in the UK.This is a hybrid role with an expectation of 2-3 days per week in...


  • UK, UK, United Kingdom Discover International Full time

    Position Overview:We are seeking an experienced and driven Manager or Senior Manager, Regulatory Affairs specializing in Cell and Gene Therapy to join our team. This role will play a pivotal part in leading regulatory strategies and ensuring the successful approval and post-approval management of cutting-edge cell and gene therapy products. The Senior...


  • UK / EU / Switzerland / Remote, UK, United Kingdom myGwork Full time

    This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Role Summary With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Senior Manager, Regulatory...


  • UK, UK, United Kingdom CT19 Full time

    Senior Director Regulatory Affairs, Global Therapeutic Area HeadLocation: Candidate must have Right to Work in the UKRemote Working with International travel to HQ requiredAbout the company:We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of...


  • UK, UK, United Kingdom Vertex Resourcing Full time

    Regulatory Affairs Lead - Challenger BrandDriving Compliance Strategy - Rapid Growth CPG Co.Job DescriptionIf you’re an aspiring reg affairs leader with a passion for driving growth via delivery of expert compliance strategy, this is one for you!Reporting directly to the Head of Marketing / Innovation, this newly created role will see you take the lead in...


  • UK, UK, United Kingdom Vertex Resourcing Full time

    Regulatory Affairs Lead - Challenger BrandDriving Compliance Strategy - Rapid Growth CPG Co.Job DescriptionIf you’re an aspiring reg affairs leader with a passion for driving growth via delivery of expert compliance strategy, this is one for you!Reporting directly to the Head of Marketing / Innovation, this newly created role will see you take the lead in...


  • UK, UK, United Kingdom ProductLife Group Full time

    Due to continued expansion we are currently seeking an additional Senior Regulatory Affairs Executive to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key part of a growing company in the pharmaceutical...


  • UK, UK, United Kingdom CT19 Full time

    Head of Regulatory Affairs CMCLocation: Remote in Europe (with travel to HQ required)About the jobWe are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their programs, which have now been launched in markets around the world. The portfolio now...


  • UK, UK, United Kingdom Planet Pharma Full time

    Job: Regional Regulatory Affairs Senior AssociateContract: 12 Month ContractLocation: Remote with occasional presence in Cambridge or UxbridgeCompany: A Global biopharmaceutical companyAbout the RoleJoin a dedicated team of regulatory professionals providing expert regional regulatory leadership and execution across Europe. This role focuses on the...


  • London,, UK, United Kingdom Warman O'Brien Full time

    Regulatory Affairs ManagerWarman O'Brien are searching for a Regulatory Affairs Manager for a globally renowned pharmaceutical business that manufactures Generic products in the UK.The role has arisen due to an increase in workload as the team looks to expand in the UK.This is a hybrid role with an expectation of 2-3 days per week in office.Regulatory...


  • ;Homeworking, , UK;Homeworking,, UK, United Kingdom Parexel Full time

    We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment.This is a client dedicated project,...

  • Regulatory Specialist

    2 weeks ago


    UK, UK, United Kingdom William Parker Group Full time

    Are you ready to take the next step in your regulatory affairs career? We are partnering with a leading pharmaceutical organisation to find a skilled Regulatory Affairs Specialist who is passionate about ensuring compliance and safeguarding patient safety. This exciting role offers the opportunity to work across UK, EU, and global markets.Key...