Regulatory Affairs Officer
19 hours ago
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.
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Regulatory Affairs Officer
19 hours ago
Maidenhead, United Kingdom Select Pharma Full timeAn 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...
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Regulatory Affairs Associate
19 hours ago
Maidenhead, United Kingdom Select Pharma Full timeAn 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...
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Select Pharma | Regulatory Affairs Officer
19 hours ago
Maidenhead, United Kingdom Select Pharma Full timeAn 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...
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Regulatory Affairs Professional
17 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full timeAre 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...
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Regulatory Affairs Associate
2 days ago
Maidenhead, United Kingdom Select Pharma Careers Full timeAn 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...
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Pharmaceutical Regulatory Affairs Specialist
19 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeWe 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...
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Regulatory Affairs Executive
19 hours ago
Maidenhead, United Kingdom Select Oh Full timeAn 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...
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Regulatory Affairs Executive
19 hours ago
Maidenhead, United Kingdom Select Oh Careers Full timeAn 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...
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Select Oh | Regulatory Affairs Manager
19 hours ago
Maidenhead, United Kingdom Select Oh Full timeAn 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...
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Select Oh | Regulatory Affairs Executive
19 hours ago
Maidenhead, United Kingdom Select Oh Full timeAn 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...
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Regulatory Affairs Specialist
4 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full timeAre 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...
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Pharmaceutical Regulatory Expert
17 hours 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...
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UK Regulatory Compliance Expert
24 hours 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...
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Regulatory Affairs Professional
1 day ago
Maidenhead, United Kingdom Adepto Technical Recruitment Ltd Full timeKey TasksSupport the IPV function with two-way communication, ensuring timely responses to queries, organisation of meetings, production of written communication, etc.Coordinate routine tasks such as onboarding and offboarding activities for Safety Officers, PSMF updates, reconciliation, etc.Maintain documentation necessary for IPV activities, such as Safety...
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Head of Government Affairs, UK
1 week ago
Maidenhead, United Kingdom AbbVie Full timeAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan...
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Post-Approval Activities Professional
1 day ago
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 -...
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Generic Pharmaceutical Compliance Manager
16 hours ago
Maidenhead, Windsor and Maidenhead, United Kingdom Select OH Full timeJob 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...
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Senior Pharmacovigilance Specialist
4 weeks ago
Maidenhead, Windsor and Maidenhead, United Kingdom CSL Behring Full timeRole OverviewWe are seeking an experienced Senior Pharmacovigilance Specialist to join our team at CSL Vifor, responsible for managing the local pharmacovigilance system within CSL Vifor UK and Ireland.You will work closely with colleagues to establish and maintain local PV systems in compliance with national regulations and GSPV policies, ensuring seamless...
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Head of Government Affairs, UK
2 weeks ago
Maidenhead, Berkshire, United Kingdom Allergan Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products...
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Regional Safety Officer
3 weeks ago
Maidenhead, United Kingdom Csl Vifor Full timeThe primary objective of the United Kingdom and Ireland (UK/IE) Regional Safety Officer (RSO) position is to manage the local pharmacovigilance (PV) system within CSL Vifor UK and Ireland, ensuring compliance with applicable PV regulations and guidelines as well as corporate and Global Safety & Pharmacovigilance (GSPV) policies.This position provides expert...