Regulatory Affairs Expert
1 day ago
We are seeking a highly experienced Director EU Regulatory Strategy to join our team at Planet Pharma. This is a temporary position for an initial 6 months, working fully remote in the UK.
The ideal candidate will have a proven track record of leading successful engagements with the EMA and deep understanding of EU regulatory requirements.
Responsibilities:
- Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA)
- Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
- Maintain currency of EU regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
- Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance
- Provide support to local regulatory experts in Rest of World to support applications and reviews.
Requirements:
- Education in life sciences required
- Proven experience in biopharmaceutical industry with deep understanding of EU regulatory requirements
- Demonstrated experience of leading successful engagement with EMA
- Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred.
- Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
- Strong written, verbal communication skills, and interpersonal skills
- Capable of managing shifting priorities in a rapidly changing environment
- Ability to travel domestically and internationally (~10%)
Estimated Salary: £85,000 - £120,000 per annum, depending on experience.
-
Regulatory Affairs Expert
5 days ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom BCL Legal Full timeAbout the RoleBCL Legal is seeking a highly experienced Regulatory Affairs Expert to join our team in Newcastle. As a leading legal firm, we are committed to delivering exceptional service to our clients while maintaining the highest standards of compliance and ethics.In this critical role, you will be responsible for ensuring that our practices, records,...
-
Regulatory Affairs Director
1 day ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Planet Pharma Full timePlanet Pharma is a leading pharmaceutical company with a strong presence in the UK, seeking an experienced Regulatory Affairs Director to lead our EU regulatory strategy.The successful candidate will have a deep understanding of EU regulatory requirements and a proven track record of leading successful engagements with the European Medicines Agency...
-
Solicitor for Regulatory Affairs
6 days ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Elevate Flexible Legal Resourcing Full timeJob Title: Solicitor for Regulatory AffairsWe are seeking an experienced Solicitor/Lawyer to join our team as a Solicitor for Regulatory Affairs. The successful candidate will have a strong background in pharmaceutical regulations, intellectual property rights, and contract negotiation.About the RoleThis is an excellent opportunity to work with innovative...
-
Solicitor - Regulatory Affairs
4 days ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Sacco Mann Full timeWe are looking for a highly experienced Solicitor to join our legal team in Newcastle Upon Tyne, specializing in regulatory affairs and commercial contracts.As a key member of the team, you will assist the Legal Director in reviewing and managing contractual arrangements for various projects, ensuring compliance with relevant regulations and laws.A...
-
Regulatory Affairs Director
1 day ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time**About CT19**We are a European biotech organisation developing novel therapeutics for a range of rare diseases.We have achieved FDA success with a few of our programs, which have now been launched in markets around the world. Our portfolio ranges from preclinical to approved products, with multiple new indications currently being explored.**Job...
-
Regulatory Affairs Therapeutic Area Head
1 day ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full timeAbout the Company:CT19 is a pioneering European biotech organisation focused on developing cutting-edge therapeutics for rare diseases. With a strong track record of FDA success and a diverse pipeline of assets, we are committed to bringing innovative treatments to patients with unmet medical needs.Job Title: Senior Director Regulatory Affairs, Therapeutic...
-
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full timeCompany Overview:CT19 is a European biotech organisation dedicated to developing novel therapeutics for rare diseases. With a strong portfolio ranging from preclinical to approved products, the company is expanding its pipeline with multiple new indications.About the Role:This exciting opportunity is for a Senior Director to lead Regulatory Affairs as...
-
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full timeAbout CT19:We are a pioneering European biotech organisation driving innovation in rare disease therapies. Our commitment to delivering novel treatments has led to FDA success with several programmes, now launched globally.Senior Director Regulatory Affairs Job Description:In this critical role, you will lead our Regulatory Affairs team, ensuring seamless...
-
Director of Global Regulatory Strategy
1 day ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full timeWe are seeking a seasoned Senior Director Regulatory Affairs to drive regulatory strategy and compliance at CT19. With a strong track record of success in marketing applications, rare disease experience, and leadership skills, you will excel in this role.This position offers an excellent opportunity for a senior professional to make a meaningful impact on...
-
Head of Regulatory Affairs
1 day ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Planet Pharma Full timeJob OverviewWe are seeking a highly experienced Director EU Regulatory Strategy to join our team at Planet Pharma.This is a temporary position for an initial 6-month period, working fully remote in the UK. The ideal candidate will have a strong track record of leading successful MAA reviews and negotiations with EU regulatory authorities.Key...
-
Regulatory Affairs Manager
6 days ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northern Powergrid Full timeThe Ideal Candidate:Northern Powergrid is seeking a highly motivated and organised individual to manage regulatory compliance tasks. The ideal candidate will have strong analytical and communication skills, as well as experience working in a regulatory environment.Key Responsibilities:Assure accuracy and timeliness of regulatory submissionsMaintain...
-
Regulatory Affairs Professional
1 day ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Northern Powergrid Full timeNorthern Powergrid is at the forefront of delivering a power network that meets the region's needs, now and in the future. As a Compliance and Risk Manager, you will play a crucial role in ensuring that the company meets its regulatory and legislative obligations in an accurate, robust and timely way.You will be responsible for managing the regulatory...
-
Regulatory Strategy Lead
6 days ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Planet Pharma Full timePlanet Pharma is a leading pharmaceutical company seeking a highly skilled Regulatory Strategy Lead to join our team on a temporary basis, working remotely in the UK. The initial 6-month contract offers an excellent opportunity for experienced professionals to showcase their expertise.The successful candidate will be responsible for leading MAA reviews,...
-
Regulatory Framework Specialist
7 days ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Azets Full timeJob Title: Regulatory Framework SpecialistAzets is looking for a seasoned Regulatory Framework Specialist to join our team and contribute to the development and implementation of our regulatory compliance framework. As a key member of our Wealth Management team, you will play a critical role in ensuring that all activities comply with relevant laws and...
-
Regulatory Expert
4 weeks ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Grace Media Full timeAbout the Role:We are looking for a Compliance Manager to join our team at Fortuna Gaming. The successful candidate will be responsible for ensuring full adherence to regulatory requirements, developing policies, and overseeing compliance activities.Key Responsibilities:Regulatory Compliance: Ensure full adherence to regulatory requirements, partnering with...
-
Regulatory Product Expert
2 days ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom LeoVegas Group Full timeAbout the RoleWe are looking for an experienced and skilled Regulatory Product Expert to join our team at the LeoVegas Group. As a key member of our compliance function, you will play a critical role in ensuring that our regulated products adhere to applicable laws, regulations, and guidelines in the Central Europe region.The successful candidate will be...
-
Senior Regulatory Affairs Professional
4 weeks ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom BioTalent Full timeGMP Compliance Manager Job Summary:BioTalent is seeking a highly experienced and qualified GMP Compliance Manager to join its team. In this critical role, you will be responsible for ensuring compliance with regulatory requirements and driving quality improvements across the organization.Key Responsibilities:Develop and implement effective GMP compliance...
-
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Focus Management Consultants Full time**Food Regulatory Advisor Role**This is a unique opportunity to work as a Food Regulatory Advisor in a business that values technical excellence and has a long-term roadmap.The role will involve providing expert advice on labelling, nutrition, and consumer information to help the company maintain compliance with food regulations. You will also be responsible...
-
Regulatory Affairs Professional
5 days ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Clayton Davies Full timeCareer Opportunities: Compliance Officer at Clayton DaviesWe are seeking a highly motivated and experienced Compliance Officer to join our team at Clayton Davies. As a Compliance Officer, you will play a key role in ensuring the successful onboarding of new firms into our company.Job Description:Oversight of compliance workstreams to ensure a seamless...
-
Director of Regulatory Compliance
1 day ago
Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom CT19 Full time**CT19 Overview**We are a dynamic biotech organisation passionate about developing innovative therapies for rare diseases.We have achieved significant milestones in our journey, including FDA approvals and product launches in global markets.**Job Description:**This is an exciting opportunity to join us as Senior Director Regulatory Affairs, Therapeutic Area...