Regulatory Affairs Specialist
3 weeks ago
Exciting opportunity: Regulatory Affairs Specialist for a growing generics pharmaceutical manufacturer.
They are looking for an individual that is hard working and self-motivated to assist with all things regulatory.
Responsibilities will include:
- Oversee all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs)
- Assist in the preparation, compilation, and publication of documentation for the Common Technical Document (CTD) dossier.
- Implement and communicate MA changes to relevant stakeholders, ensuring all compliance activities are effectively managed.
- Collaborate with in-house teams, third-party designers, and contract sites to develop and update packaging artwork.
- Create and maintain patient information leaflets and packaging components, managing artwork to ensure compliance with regulatory standards and compnay approval systems.
- Liaise with various departments, clients, and regulatory authorities to ensure effective communication.
- Maintain regulatory files, databases, and document chronologies, and track changes in documents submitted to agencies or partners.
- Support New Product Development and Lifecycle Management projects.
- Lead and/or assist in submitting licenses and authorizations for new products and modifications to existing products.
- Prepare responses to regulatory agency inquiries to facilitate timely post-submission approvals.
- Provide regulatory support during internal and external audits.
Competencies:
- Bachelors degree required, ideally in sciences, engineering, medical/scientific writing, or public health administration.
- At least 2 years of experince in Regulatory Affairs or a related field.
- Proven experince in preparing technical documentation for regulatory submissions.
- Strong verbal and written communication skills, with the ability to interact effectively with stakeholders.
- Ability to work independently and manage daily regulatory responsibilities for a product portfolio.
Please share your CV at e.smailes@x4lifesciences.com if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.
-
Regulatory Affairs Specialist
4 days ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeJob Overview:Regulatory Affairs SpecialistX4 Life Sciences is a growing pharmaceutical manufacturer seeking an experienced Regulatory Affairs Specialist to join their team.Estimated Salary: £42,000 per annum.Key Responsibilities:Oversee the lifecycle maintenance of registered Marketing Authorizations (MAs).Assist in preparing and publishing documentation...
-
Regulatory Affairs Specialist
4 days ago
Hertfordshire, United Kingdom AJ FOX COMPLIANCE Full timeJob Title: Regulatory Affairs SpecialistEstimated Salary: £55,000 - £75,000 per annumCompany Overview:AJ FOX COMPLIANCE is a forward-thinking law firm seeking a Regulatory Affairs Specialist to join their team.In this role, you'll work closely with the Head of Risk and Compliance, collaborating across the business to embed a strong compliance culture.Key...
-
Regulatory Affairs Specialist
1 week ago
Hertfordshire, United Kingdom AJ FOX COMPLIANCE Full timeAJ FOX COMPLIANCE requires an experienced Regulatory Affairs Specialist to oversee and implement effective regulatory strategies. You will work closely with internal stakeholders to ensure compliance with regulatory requirements and provide expert guidance on complex issues.Responsibilities:Develop and implement regulatory strategies to ensure compliance...
-
Regulatory Affairs Specialist
2 weeks ago
Hertfordshire, United Kingdom Compliance Professionals Full timeJob Title: Regulatory Affairs SpecialistAbout Us: Compliance Professionals is a boutique financial services firm based in St Albans. We are seeking a Regulatory Affairs Specialist on a permanent basis.Responsibilities:Ensure regulatory compliance: Monitor, analyse and report on regulatory changes to ensure the business remains compliant.Provide guidance:...
-
Regulatory Affairs Specialist Lead
2 weeks ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeJob OverviewX4 Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to oversee the lifecycle maintenance of registered Marketing Authorizations (MAs) for our growing generics pharmaceutical portfolio.The ideal candidate will have at least 2 years of experience in Regulatory Affairs or a related field, with a proven track record of...
-
Regulatory Affairs Specialist
1 month ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeJob Description Exciting opportunity: Regulatory Affairs Specialist for a growing generics pharmaceutical manufacturer. They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include: Oversee all aspects of the lifecycle maintenance for registered Marketing Authorizations...
-
Regulatory Affairs Professional
1 week ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at X4 Life Sciences. As a key member of our Regulatory team, you will be responsible for overseeing all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs).The ideal candidate will have a strong background in Regulatory Affairs, with...
-
Regulatory Affairs Manager
1 week ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeRegulatory Affairs Position at X4 Life SciencesX4 Life Sciences is seeking a skilled Regulatory Affairs Specialist to join our team in Hertfordshire, UK. This role involves assisting with the submission of licenses and authorizations for new products and modifications to existing products.Key Responsibilities:Assist in the preparation and submission of...
-
Regulatory Affairs Specialist
1 week ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeCompany OverviewX4 Life Sciences is a leading biotechnology company dedicated to developing innovative solutions for the healthcare industry.We are seeking a highly experienced Regulatory Affairs Specialist to join our team and play a key role in ensuring compliance with regulatory requirements.
-
Quality Assurance Manager
1 week ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeRegulatory Affairs Specialist Job Description:X4 Life Sciences is seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team. This role offers an exciting opportunity to work in a fast-paced and collaborative environment where you will be responsible for ensuring that our products comply with regulatory requirements.Key...
-
Regulatory Affairs Professional
1 week ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeWe are seeking a talented Regulatory Affairs Professional to join our team at X4 Life Sciences. The successful candidate can expect a salary of $90,000 - $115,000 per annum, based on their qualifications and experience.Key Responsibilities:This role involves overseeing all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs).The...
-
Regulatory Affairs Manager
6 days ago
Hertfordshire, United Kingdom AJ FOX COMPLIANCE Full timeJob Overview:AJ FOX COMPLIANCE is seeking a skilled Regulatory Affairs Manager to oversee our compliance processes. This role involves collaborating with senior leadership and various departments to ensure we comply with all relevant legal, regulatory, and professional standards.Key responsibilities include offering advice on legal, ethical, and regulatory...
-
Regulatory Affairs Manager
3 days ago
Hertfordshire, United Kingdom AJ FOX COMPLIANCE Full timeWe are seeking an experienced Regulatory Affairs Manager to join our AJ Fox Compliance team. As a key member of our team, you will collaborate with senior leadership and departments to ensure compliance with legal, regulatory, and professional standards.A competitive salary range of $90,000 - $120,000 per annum is available for this position, depending on...
-
Regulatory Affairs Director
3 days ago
Hertfordshire, United Kingdom AJ FOX COMPLIANCE Full timeAJ FOX Compliance is a dynamic and growing organization seeking a Regulatory Affairs Director to lead our compliance efforts.The successful candidate will have a deep understanding of regulatory requirements and be able to communicate complex information to stakeholders.Salary: £80,000 per annum, depending on experience. A competitive salary package...
-
Regulatory Compliance Specialist
1 week ago
Hertfordshire, United Kingdom X4 Life Sciences Full timeAbout the RoleThis position is a fantastic opportunity for an experienced Regulatory Affairs Specialist to join X4 Life Sciences in Hertfordshire, UK. As a key member of our team, you will be responsible for overseeing all aspects of the lifecycle maintenance for registered Marketing Authorizations (MAs).Key Responsibilities:Maintain and update regulatory...
-
Regulatory Affairs Manager
4 days ago
Hertfordshire, United Kingdom AJ FOX COMPLIANCE Full timeOverviewAJ FOX COMPLIANCE is a dynamic and innovative law firm seeking a Regulatory Affairs Manager to join our proactive team.In this role, you will work closely with senior leadership and various departments to ensure that the firm complies with all relevant legal, regulatory, and professional standards.Key Responsibilities:Collaborate with senior...
-
Regulatory Affairs Specialists
2 days ago
Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full timeAre you looking to advance your career in regulatory affairs? At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you are...
-
Pharmaceutical Regulatory Affairs Specialist
2 days ago
Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full timeAre you looking to advance your career in regulatory affairs? At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you are...
-
Hertfordshire, United Kingdom Compliance Professionals Full time**Regulatory Expert Wanted: Head of Regulatory Affairs and Risk ManagementWe are a leading financial services firm seeking a highly skilled professional to oversee our regulatory affairs and risk management functions.The ideal candidate will have extensive experience in legal, compliance, and AML roles, within the financial services space- ideally from a...
-
Regulatory Affairs Manager
6 days ago
Hertfordshire, United Kingdom AJ FOX COMPLIANCE Full timeRisk Management Specialist OpportunityAJ FOX COMPLIANCE is looking for a highly skilled Risk Management Specialist to join our team. The successful candidate will work closely with the Head of Risk and Compliance, providing expert guidance on regulatory and risk issues.Key Responsibilities:Collaborate with senior leadership and other departments to ensure...