Chemical Regulatory Expert
3 days ago
- Convert an existing application to eCTD format
- Prepare and submit Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company
- Ensure completion of post-approval commitments
- Compile and maintain Product license files
- Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs
To be successful in this role, you will need:
- A Pharmacy/Chemistry degree
- 1-2 years Regulatory Affairs experience
- Understanding of the current UK and European regulations, laws, guidelines, and industry requirements
- Exposure to NeeS/eCTD format and electronic submission gateways is preferable
We offer a competitive salary of £28,000-£34,000 per year, a bonus scheme, company pension, free parking, and on-site parking. The role is full-time, Monday to Friday, with the possibility of overtime.
-
Regulatory Compliance Expert
3 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeAt Select Pharma Limited, we are seeking a highly skilled Regulatory Compliance Expert to join our growing team. With a focus on post-approval activities, this exciting opportunity offers the chance to expand your experience and knowledge in regulatory compliance.About the Role:This position involves converting existing applications to eCTD format, preparing...
-
Pharmaceutical Regulatory Expert
2 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Full time**Job Summary**Select Pharma is looking for an enthusiastic and experienced Regulatory Affairs professional to join its growing Reg team. The ideal candidate will have a strong background in Regulatory compliance and a proven track record of successfully managing post-approval activities.The estimated salary for this role is around $90,000 - $120,000 per...
-
Regulatory Affairs Expert
12 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeSelect Pharma Limited is seeking a highly skilled and motivated Regulatory Affairs professional to join its growing Reg team. As an Asset Compliance Specialist, you will play a crucial role in ensuring the company's compliance with post-approval regulations.About the RoleThis exciting opportunity involves converting existing applications to eCTD format,...
-
Post-Approval Compliance Professional
3 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeJob DescriptionAs a Chemical Regulatory Expert, you will be responsible for converting an existing application to eCTD format, preparing and submitting Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company. You will also ensure completion of post-approval commitments, compile and maintain Product license...
-
Regulatory Affairs Professional
10 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full timeAre you an experienced Regulatory Affairs professional looking for a new challenge? Select OH is seeking a Senior Compliance Officer to join our team in a growing generic pharmaceutical company. This exciting opportunity will see you work on post-approval and compliance activities, supporting the pre-approval team as needed.We are offering a competitive...
-
Regulatory Compliance Expert
2 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full timeFearless problem-solvers and creative thinkers wanted! We are actively seeking individuals who share our passion for overcoming barriers in clinical trials. As a member of our Trial Master File (TMF) Team, you will play a critical role in the success of our clinical trials by ensuring the organization, accessibility, and compliance of essential clinical...
-
UK Regulatory Compliance Expert
2 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full timeAre you ready for a new challenge in regulatory affairs? We are currently seeking an experienced Regulatory Affairs Executive to join our team at Select OH, based in Berkshire.About the JobThis is an exciting opportunity to join a dynamic team focused on cGMP, solid dosage generic pharmaceuticals. As a key member of our team, you will be responsible for...
-
Post-Approval Regulatory Lead
6 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full timeAbout This OpportunityWe are excited to offer a challenging and rewarding role for a skilled Regulatory Affairs Manager to join our team at Select OH. This is a fantastic opportunity to take on new challenges and contribute to the success of our company.Key ResponsibilitiesCompliance and regulatory activities: Ensuring compliance with regulatory requirements...
-
Pharmacovigilance Expert with Safety Focus
2 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Biogen, Inc. Full timeAbout the RoleWe are seeking an experienced Pharmacovigilance Scientist to join our team at Biogen, Inc. As a Senior Pharmacovigilance Scientist, you will be responsible for overseeing pharmacovigilance activities, including safety signal management, aggregate reporting, and responding to regulatory queries. You will also serve as a Subject Matter Expert on...
-
Quality Management Systems Expert
6 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom CV Library Full timeChelton, a leading player in the aerospace sector, is seeking a Quality Management Systems Expert to join their team. In this role, you will be responsible for ensuring strict adherence to EASA, CAA, and Part 21G regulations, maintaining compliance across all production activities.Key ResponsibilitiesDevelop and implement quality management systems to ensure...
-
Senior Quality Compliance Expert
1 month ago
Maidenhead, Windsor and Maidenhead, United Kingdom Orion Electrotech Full timeOrion Electrotech is a leading player in the aerospace sector seeking a skilled Senior Quality Compliance Expert with expertise in EASA, CAA, and Part 21G regulations.About the RoleThis position offers the opportunity to maintain the highest standards of quality across aerospace manufacturing and compliance processes. The ideal candidate will have a strong...
-
Senior Pharmacovigilance Expert
12 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Biogen, Inc. Full timeAbout the RoleWe are seeking a highly skilled Safety Data Analyst Lead to join our team at Biogen, Inc. in this key role of Senior Pharmacovigilance Expert.In this position, you will be responsible for leading safety signal management activities and overseeing the process for aggregate reports (PSURs, DSURs, Line Listings, RMPs). You will also respond to...
-
Post-Approval Expert
3 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full timeSelect OH is a prominent player in the generic pharmaceutical industry, with a strong focus on delivering high-quality products to customers. We are now looking for an experienced Regulatory Affairs Manager to lead our post-approval operations.Job RequirementsAs a key member of our team, the successful candidate will be responsible for executing and...
-
Senior Legal Counsel
2 months ago
Maidenhead, Windsor and Maidenhead, United Kingdom Taylor Root Full timeJob Title: Senior Legal CounselAbout the Role:We are seeking a highly experienced Senior Legal Counsel to join our team at Taylor Root. As a Senior Legal Counsel, you will be responsible for providing expert legal advice on commercial and corporate agreements across multiple jurisdictions.Key Responsibilities:Providing legal advice on commercial and...
-
Submission Expert for Marketing Authorization
2 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full timeKey ResponsibilitiesDocument Accuracy and Compliance: Check documents for accuracy, consistency, deficiencies, and compliance with regulatory submission requirements.Compilation and Submission: Compile module 1-5 CTD registration package for new Marketing Authorisation submissions and submit necessary applications through electronic channels.Collaboration...
-
Compliance and Governance Expert
2 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Glencore Full timeWe are looking for a highly skilled Compliance Officer to join our KYC Quality Assurance team at Glencore in Maidenhead. The ideal candidate will have a strong background in risk management and compliance, with excellent analytical skills and attention to detail.About the Role: This position involves working closely with compliance teams across various...
-
Marketing Authorisation Specialist
3 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full time**About Us:** Select OH is a leading company in the field of regulatory compliance, committed to delivering high-quality submissions that meet the strict requirements of regulatory authorities. Our team of experts works tirelessly to ensure that our clients receive exceptional service and support.">**Job Summary:** We are seeking a highly skilled Marketing...
-
Senior Label Operations Manager
2 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Biogen Full timeBiogen is committed to fostering a culture of innovation, diversity, and inclusion. As a member of our team, you will have the opportunity to work with cutting-edge technologies, collaborate with experts from various backgrounds, and contribute to the development of life-changing medicines.Job SummaryThe Senior Associate, Planning role is responsible for...
-
Contract Lawyer
7 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Ashville Knight Full time £55,000About Ashville Knight:Ashville Knight is a well-established law firm in Berkshire seeking a highly skilled Commercial Solicitor to join their team. This is an excellent opportunity for a dedicated lawyer to work closely with clients, providing expert advice and guidance on commercial contracts and related matters. The successful candidate will have a strong...
-
Senior Clinical Research Associate
1 month ago
Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full timeClinical Development SolutionsFortrea provides a comprehensive range of clinical development services, including study management, data analysis, and regulatory support. Our team of experts works closely with clients to deliver tailored solutions that meet their unique needs.Career OpportunitiesThis role offers a chance to advance your career in a dynamic...