Select Pharma | Regulatory Affairs Officer

19 hours ago


Maidenhead, United Kingdom Select Pharma Full time

An exciting opportunity has become available with my client, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team.
With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of Regulatory compliance as well as the opportunity to supervise and guide a team.
Responsibilities: Converting an existing application to eCTD format.
Preparation and submission of Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company.
Ensure completion of post-approval commitments, if any.
Compilation and maintaining Product license files.
Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs.
Process and communicate regulatory approvals internally and to external stake holders.
Participate to the review of process/product changes, deviations, product complaints, adverse drug reactions, medical information, and batch recall to determine the need for any regulatory activities and to ensure compliance to regulatory requirements.
Maintain regulatory files/database and chronologies in good order.
Maintain system for tracking changes in documents submitted to agencies or partners.
Publishing activities including converting/binding of pdf files, resolve validation issues.
Compile and submit variations.
Working in accordance with Companys working Instructions and SOPs.
Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department Required Experience: Pharmacy/Chemistry degree 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.
Experience with Generic products and MRP/DCP submissions is advantageous.
JBRP1_UKTJ



  • 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...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

    We are looking for a skilled Pharmaceutical Regulatory Affairs Specialist to join our team at Select Pharma Limited. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with regulatory requirements.About the Role:In this position, you will be responsible for converting existing applications to eCTD...


  • Maidenhead, United Kingdom Select Pharma Full time

    An exciting opportunity has become available with my client, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team.If your skills, experience, and qualifications match those in this job overview, do not delay your application.With a focus on...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Full time

    **Job Description**Select Pharma is a rapidly expanding pharmaceutical company that requires an experienced Regulatory Affairs professional to join its team. The successful candidate will have a strong background in Regulatory compliance and be able to effectively manage post-approval activities.The estimated salary for this role is around $100,000 -...


  • Maidenhead, United Kingdom Select Pharma Full time

    An exciting new opportunity has arisen for a Regulatory Affairs Associate to join my client, a growing pharmaceutical company based in Berkshire.This role will suit a regulatory professional at the beginning of their career please note that 6 months to 1 year of regulatory experience is required.Interested in learning more about this job Scroll down and find...


  • Maidenhead, United Kingdom Select Pharma Careers Full time

    An exciting opportunity has become available with my client, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team.With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of Regulatory compliance...


  • Maidenhead, United Kingdom Select Pharma Careers Full time

    An exciting new opportunity has arisen for a Regulatory Affairs Associate to join my client, a growing pharmaceutical company based in Berkshire. This role will suit a regulatory professional at the beginning of their career please note that 6 months to 1 year of regulatory experience is required.++ Please note that this role is fully office based (5 days...


  • Maidenhead, United Kingdom Select Oh Full time

    An exciting opportunity for an experienced Regulatory Affairs Manager to take on a new role in a growing generic pharmaceutical company working towards a portfolio of 220 licenses.Responsibilities: Primarily responsible for post-approval and compliance activities with a support role for the pre-approval team Have an excellent understanding of and be able to...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full time

    Are you a skilled professional looking for a challenging opportunity in regulatory affairs?About the RoleWe are seeking a highly motivated and experienced Regulatory Affairs Executive to join our team at Select OH, based in Berkshire. This exciting role will focus on cGMP, solid dosage generic pharmaceuticals.As a key member of our team, you will be...


  • Maidenhead, United Kingdom Select Oh Full time

    An excellent opportunity has arisen for a Regulatory Affairs Executive to join my client based in Berkshire and focusing on cGMP, solid dosage generic pharmaceuticals.Responsibilities: Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure.These include new licence applications, variations (including...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

    Are you an enthusiastic Regulatory Affairs professional looking to expand your experience and knowledge in a growing pharmaceutical company? We have an exciting opportunity for a skilled Chemical Regulatory Specialist to join our team!About the Role:We are seeking an experienced professional to lead post-approval activities, ensuring compliance with...


  • Maidenhead, United Kingdom Select Oh Full time

    An excellent opportunity has arisen for a Regulatory Affairs Executive to join my client based in Berkshire and focusing on cGMP, solid dosage generic pharmaceuticals.Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.Responsibilities: Prepare and submit applications of reliable quality in...


  • Maidenhead, United Kingdom Select Oh Careers Full time

    An excellent opportunity has arisen for a Regulatory Affairs Executive to join my client based in Berkshire and focusing on cGMP, solid dosage generic pharmaceuticals.Responsibilities: Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure.These include new licence applications, variations (including...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full time

    Are 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...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full time

    Job DescriptionAn exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join our team at Select OH. As a key member of our post-approval team, you will be responsible for managing licenses and maintaining regulatory relationships.The ideal candidate will have a strong understanding of the generic pharmaceutical industry and be able...


  • Maidenhead, United Kingdom Verbatim Pharma Full time

    Head of Quality - Pharmaceutical Industry - Hybrid Opportunity (3 days on site, 2 at home) Are you ready to advance your career with a niche leader in Clinical Pharma? Providing the opportunity to specialise in a niche area of a business who have 3 key divisions, providing exposure to an area of the pharmaceutical industry being directly involved in saving...


  • Maidenhead, United Kingdom Verbatim Pharma Full time

    Head of Quality - Pharmaceutical Industry - Hybrid Opportunity (3 days on site, 2 at home) Are you ready to advance your career with a niche leader in Clinical Pharma?Providing the opportunity to specialise in a niche area of a business who have 3 key divisions, providing exposure to an area of the pharmaceutical industry being directly involved in saving...


  • Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full time

    Join us at Select OH, a leading generic pharmaceutical company, where we are seeking an experienced Regulatory Affairs Manager to join our team. As part of our continued growth, this is an exciting opportunity to take on a new challenge in a dynamic environment.About the RoleThis key position will be responsible for ensuring that all post-approval activities...


  • Maidenhead, United Kingdom Verbatim Pharma Full time

    Head of Quality - Pharmaceutical Industry - Hybrid Opportunity (3 days on site, 2 at home)Are you ready to advance your career with a niche leader in Clinical Pharma? Providing the opportunity to specialise in a niche area of a business who have 3 key divisions, providing exposure to an area of the pharmaceutical industry being directly involved in saving...


  • Maidenhead, United Kingdom Verbatim Pharma Full time

    Head of Quality - Pharmaceutical Industry - Hybrid Opportunity (3 days on site, 2 at home)Are you ready to advance your career with a niche leader in Clinical Pharma? Providing the opportunity to specialise in a niche area of a business who have 3 key divisions, providing exposure to an area of the pharmaceutical industry being directly involved in saving...