Biotech Regulatory Strategist

4 weeks ago


London, Greater London, United Kingdom Stirling Q&R Full time

We are looking for a highly skilled Biotech Regulatory Strategist to join our team at Stirling Q&R. As a Senior Director of Regulatory Affairs, you will be responsible for leading the regulatory strategy and operations for our esteemed client in the biotech industry.

Key Responsibilities
  • Develop and implement regulatory strategies to support product development and market access for biopharmaceutical products.
  • Lead a team of regulatory professionals to ensure the timely preparation and submission of high-quality regulatory documentation to health authorities, including INDs, BLAs, and MAAs.
  • Advise cross-functional teams on regulatory requirements and provide guidance on compliance during research and development stages.
  • Establish and maintain relationships with regulatory agencies and act as the primary point of contact during agency interactions.
  • Monitor and assess changes in regulations and guidelines to provide strategic insights to the team and company leadership.
  • Oversee the preparation for regulatory submissions and inspections, ensuring adherence to best practices.
  • Mentor and develop regulatory staff, fostering a culture of excellence and accountability.

The ideal candidate will have a strong background in regulatory affairs and a minimum of 8 years of experience in the pharmaceutical or biotechnology industries, with at least 5 years in a leadership role.

Compensation Package
  • Competitive salary: $150,000 - $200,000 per year
  • Private Health Insurance
  • Pension Plan
  • Work From Home


  • London, Greater London, United Kingdom VRS Regulatory Full time

    Role OverviewA challenging opportunity has arisen for a Regulatory Affairs Strategist to join VRS Regulatory's team. About the RoleWe are seeking an experienced Regulatory Affairs Strategist to develop and implement regulatory strategies for plant protection products in specific geographical territories. Develop and execute regulatory strategies for product...


  • London, Greater London, United Kingdom Venn Group Full time

    Job Description: Banking Regulatory StrategistWe are seeking an experienced banking regulatory strategist to join our team. This is a critical role that requires a deep understanding of UK regulatory frameworks, including PRA and FCA standards. As a Banking Regulatory Strategist, you will be responsible for providing strategic advice to senior management on...


  • London, Greater London, United Kingdom Vixio Regulatory Intelligence Full time

    Job Title: SaaS Product StrategistAbout Vixio Regulatory Intelligence:Vixio Regulatory Intelligence is a leading provider of RegTech solutions aimed at mitigating compliance risks in the payments and gambling sectors. Our mission is to empower businesses to efficiently manage regulatory obligations through innovative SaaS tools.Job Summary:We are seeking a...


  • London, Greater London, United Kingdom GSK Full time

    Regulatory Strategist Job OverviewGSK is seeking an experienced Regional Regulatory Strategist to join our team. As a key member of our regulatory affairs team, you will play a critical role in developing and implementing regional regulatory strategies to support the development program.About the RoleYou will collaborate with cross-functional teams to ensure...


  • London, Greater London, United Kingdom DivalentineCalver Recruitment Ltd Full time

    Regulatory Affairs Strategist Job SummaryWe are seeking an experienced Regulatory Affairs Strategist to join our team. As a key member of our Regulatory affairs function, you will be responsible for developing and maintaining Regulatory strategies for existing ingredients and new ingredients/products in the UK and EU regions.The successful candidate will...


  • London, Greater London, United Kingdom AstraZeneca Taiwan Full time

    AstraZeneca Taiwan seeks an experienced Regulatory Affairs Strategist to play a pivotal role in identifying and executing regulatory strategies that support commercial objectives.Job DescriptionKey Responsibilities:Develop and implement regulatory strategies to ensure compliance with UK regulations.Manage the regulatory process, including planning and...


  • London, Greater London, United Kingdom Financial Conduct Authority Full time

    About the RoleWe are seeking an experienced Insurance Regulatory Strategist to join our Fixed Retail Insurers Supervision Team in the Market Interventions Insurance Division at the Financial Conduct Authority (FCA).


  • London, Greater London, United Kingdom CK Group Full time

    European Regulatory Procedural Strategist Role OverviewThe European Regulatory Procedural Strategist (ERPS) team plays a crucial role in managing the procedural and operational aspects of European regulatory filings within the Centralised Procedure. This involves close collaboration with the European Regulatory Liaison group and other regional and global...


  • London, Greater London, United Kingdom X4 Life Sciences Full time

    A highly experienced Regulatory Affairs Strategist is needed to develop and implement EU regulatory strategies for medical devices at X4 Life Sciences, a growing London-based company. This role oversees the management of technical files, dossiers, and regulatory documents.About the RoleWork closely with Notified Bodies to obtain FDA and FDR approval for...


  • London, Greater London, United Kingdom ARTHEx Biotech Full time

    About the CompanyARTHEx Biotech is a clinical-stage biotechnology company focused on developing innovative medicines through the modulation of gene expression. Our lead investigational compound, ATX-01, is being evaluated for the treatment of myotonic dystrophy type 1 (DM1), a rare neuromuscular disorder, in the Phase I-IIa ArthemiRTM trial.We are committed...


  • London, Greater London, United Kingdom Lifelancer Full time

    We are seeking a talented Marketing Communications Strategist to drive our international B2B4P marketing and communications strategy. As a key member of our team, you will create and deliver a cohesive strategy that aligns with our business goals and objectives.The ideal candidate will have a strong understanding of the pharmaceutical and biotech sectors,...


  • London, Greater London, United Kingdom Albion Rye Associates Full time

    Albion Rye Associates is seeking an experienced Financial Director to lead their biotech client through a critical period of growth and development.The ideal candidate will have a strong background in financial management, with experience in budgeting, forecasting, and reporting. They will also provide strategic guidance to the CEO and executive team on...

  • Chief AI Strategist

    3 days ago


    London, Greater London, United Kingdom Harnham Full time

    **Job Title:** Chief AI Strategist**Location:** London**Estimated Salary:** Up to £130,000 + 10% bonus + 10% Pension + Private Healthcare (4 days in office)We are seeking an experienced Chief AI Strategist to lead our growing team of AI Scientists working on high-impact, AI driven machine learning models to drive innovation in the BioTech space.Key...


  • London, Greater London, United Kingdom NatWest Group Full time

    Job OverviewNatWest Group seeks a seasoned Regulatory Compliance Learning Strategist to spearhead regulatory mandatory learning initiatives for NatWest Markets. This critical role involves developing, embedding, and maintaining regulatory learning strategies that mitigate risks and promote a proactive compliance culture.About the RoleYou will lead the design...


  • London, Greater London, United Kingdom GlaxoSmithKline Full time

    GSK is seeking a highly skilled Global Oncology Regulatory Strategist to join our team in the UK. In this role, you will develop and execute global and regional regulatory strategies for assigned assets in our growing oncology portfolio. You will ensure compliance with regulatory requirements while optimising the development programme to meet the needs of...


  • London, Greater London, United Kingdom ARTHEx Biotech Full time

    About the RoleThe Senior Project Coordinator Clinical will play a key role in the planning and execution of clinical trials within the Clinical Department at ARTHEx Biotech. This individual will be responsible for providing administrative support to ensure smooth project operations, including budget management, contract negotiation, and vendor management.The...


  • London, Greater London, United Kingdom CK Group Full time

    Job Description CK Group is recruiting for an experienced European Regulatory Procedural Strategist to join their global pharmaceutical client in Uxbridge on a contract basis for 12 months. The successful candidate will work closely with the ERPS team to manage procedural and operational aspects of European regulatory filings within the EU Centralised...


  • London, Greater London, United Kingdom Lorien Full time

    About the RoleWe are seeking an Insurance Regulatory Product Strategist to join our Lorien team on a 6-month contract. This role offers the opportunity to work on regulatory change projects and collaborate with the GRS Architecture Team and assigned Architect.The successful candidate will be responsible for defining and prioritising features, owning and...


  • London, Greater London, United Kingdom Meet Full time

    Sr. Biotech Executive OpportunityWe are looking for a seasoned Chief Scientific Officer (CSO) to lead our scientific strategy and advance cutting-edge therapies for solid tumors and hematological malignancies. As a visionary leader, you will direct research teams and preclinical translational science programs to ensure project milestones are achieved.About...


  • London, Greater London, United Kingdom Mastercard, Inc. Full time

    Job SummaryWe are seeking a skilled and experienced Regulatory Affairs Strategist to join our team at Mastercard, Inc.About the RoleThis newly created position will engage with central banks, governments, non-governmental organizations, and private sector partners on key regulatory initiatives impacting the payments industry. The successful candidate will...