Regulatory Affairs Specialist

2 days ago


Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time
Job Description:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Eli Lilly and Company. This role is responsible for establishing local regulatory strategies and plans for assigned products in the region/country, ensuring alignment with global regulatory strategies.

The ideal candidate will have a Bachelor's degree in a scientific or health sciences discipline and minimum 5 years of experience in regulatory affairs and/or drug development. Knowledge of local/regional regulatory procedures and practices is essential, as well as awareness of evolving regulatory reform initiatives.

This role requires demonstrated knowledge of the drug development process, Lilly's (or external peer company) regulatory/business strategies, and the ability to assess and manage risk in a highly regulated environment. The successful candidate will be able to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes.

Key Responsibilities:

  • To establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy (i.e. RSD) and ensure local regulations and region/country business needs are included.
  • To provide regional regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s).
  • May perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area.

Estimated Salary: $120,000 - $150,000 per year, depending on location and experience.

About Us: Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.



  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    About the RoleEli Lilly and Company is a global healthcare leader, and we are seeking a highly skilled Senior Director, Global Regulatory Affairs-EMEA to join our team. This role will be responsible for establishing the local regulatory strategy and plan for assigned products in the region/country.Key ResponsibilitiesDevelop and execute local regulatory...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    We are a global healthcare leader headquartered in the United States. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.Job Summary:The Senior Director, Global Regulatory Affairs...


  • Bracknell, Bracknell Forest, United Kingdom Signet Recruitment and Retention Full time

    We are looking for a talented Regulatory Affairs Specialist to join our team at Signet Recruitment and Retention. As a key member of our Compliance and Risk Department, you will be responsible for maintaining knowledge of ongoing regulatory change and providing day-to-day advice and guidance to the business on technical compliance matters.The ideal candidate...


  • Bracknell, Bracknell Forest, United Kingdom Signet Recruitment and Retention Full time

    Job Description:We are seeking an experienced Regulatory Affairs Manager to join our client's Compliance and Risk Department. As a key member of the team, you will be responsible for ensuring all regulatory requirements are met and providing guidance to the business on technical compliance matters.About the Role:The successful candidate will have a strong...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    About the OpportunityEli Lilly and Company is a leading pharmaceutical company, and we are looking for a talented individual to fill the role of Senior Director, Global Regulatory Affairs-EMEA. This position involves providing regional regulatory leadership and oversight in delivering high-quality and efficient regulatory submissions, approvals, and local...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    Benefits:Eli Lilly and Company offers a comprehensive rewards package, including:A highly competitive salary range of $120,000 - $180,000 per year.Benefits, including medical, dental, vision, and 401(k) retirement plan.Stock options and equity participation in company performance.Comprehensive training and professional development programs.Ongoing mentorship...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    Job Summary:Eli Lilly and Company is seeking a Global Regulatory Strategist to join our team. This role is responsible for developing and implementing global regulatory strategies for assigned products, ensuring compliance with all applicable regulations and internal quality systems.The ideal candidate will have a Bachelor's degree in a scientific or health...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    About the Role:We are seeking an experienced Associate Director of Regulatory Excellence to join our team at Eli Lilly and Company. This role is responsible for leading the development and implementation of regulatory strategies for assigned products, ensuring compliance with all applicable regulations and internal quality systems.The ideal candidate will...


  • Bracknell, Bracknell Forest, United Kingdom Signet Recruitment and Retention Full time

    About the Role">We are currently seeking an experienced Regulatory Compliance Specialist to join our team on a 6-month contract, with potential for permanent placement. The successful candidate will be responsible for managing the operational compliance function, ensuring all regulatory requirements are met, and providing day-to-day advice to the business on...


  • Bracknell, Bracknell Forest, United Kingdom Lifelancer Full time

    Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT, offers an exciting opportunity for a Medical Information Specialist to join our team.As a Medical Information Specialist at Lifelancer, you will gain a comprehensive understanding of Medical Affairs services and regulatory environments. You will be part of a supportive team, learning from...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    Job Description:We are a leading healthcare company headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.The Director of Global Regulatory...


  • Bracknell, Bracknell Forest, United Kingdom Lifelancer Full time

    We are seeking a highly motivated and organized Medical Information Specialist to join our team. This is an excellent opportunity for individuals who want to gain a rounded experience of Medical Information and Medical Affairs services.**Job Overview:**The successful candidate will work within the Medical Affairs Transformation and Operations (MATO) team,...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    About the JobEli Lilly and Company is a dynamic and innovative pharmaceutical company, and we are seeking a highly skilled professional to fill the role of Senior Director, Global Regulatory Affairs-EMEA. As a member of our team, you will be responsible for developing and executing local regulatory plans that align with the global regulatory strategy.Key...


  • Bracknell, Bracknell Forest, United Kingdom Signet Resources Full time

    Job Summary:We are seeking a highly skilled Regulatory Compliance Expert to join our team at Signet Recruitment and Retention. The successful candidate will be responsible for managing and delivering the operational Compliance and Risk function, ensuring all regulatory requirements are met through ongoing review of processes, procedures, and controls.About...


  • Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time

    Are you a quality professional looking for a new challenge? Do you have experience in quality management and medical device governance within an ISO 13485 accredited healthcare organization?We are seeking a skilled Quality and Compliance Manager to join our Clinical Product Team at HealthHero Group. In this role, you will:Provide expert guidance on product...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    Eli Lilly and Company is a global healthcare leader committed to discovering and developing innovative medicines that improve lives. We are seeking a talented Real World Evidence Scientist to join our Value, Evidence, and Outcomes (VEO) International Medical Affairs team.In this role, you will provide strategic insight and leadership into RWE for Lilly's...


  • Bracknell, Bracknell Forest, United Kingdom Brandon James Ltd Full time

    About Us:">Brandon James Ltd is a leading consultancy that collaborates with clients to deliver high-quality results.">Job Role:">">This position requires a Building Control Surveyor and/or Registered Building Inspector to work part-time (1 day/week).">The successful candidate will be responsible for site inspections, design meetings, and ensuring compliance...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    As a Senior Medical Affairs Specialist at Eli Lilly and Company, you will contribute to the acceleration of patient access and transformation of healthcare delivery through the execution and communication of cutting-edge science. This role is part of our Value, Evidence, and Outcomes (VEO) International Medical Affairs team, which focuses on delivering...


  • Bracknell, Bracknell Forest, United Kingdom Signet Recruitment and Retention Full time

    Job Summary:We are seeking an experienced Compliance and Governance Specialist to join our client's Compliance and Risk Department. As a key member of the team, you will be responsible for ensuring all regulatory requirements are met and providing guidance to the business on technical compliance matters.About the Role:The successful candidate will have a...


  • Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time

    Are you passionate about healthcare and eager to make a meaningful impact? We are seeking a skilled Senior Medical Affairs Specialist to join our team at Eli Lilly and Company. As a key member of our International Medical Affairs function, you will play a vital role in accelerating patient access and transforming healthcare delivery through the execution and...