Current jobs related to Regulatory Affairs Manager - United Kingdom - Pro4orm People Ltd
-
Specialist – Regulatory Affairs PPP
2 weeks ago
United Kingdom VRS Regulatory Full timeAn opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...
-
Specialist – Regulatory Affairs PPP
7 days ago
United Kingdom VRS Regulatory Full timeAn opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...
-
Specialist - Regulatory Affairs PPP
6 hours ago
United Kingdom VRS Regulatory Full timeAn opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will: Manage a portfolio of plant protection products in specific geographical territories Develop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory...
-
United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
-
United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
-
Regulatory Affairs Specialist
6 hours ago
United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
-
Regulatory Support Officer
2 months ago
United Kingdom VRS Regulatory Full timeA rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive training. An excellent opportunity to start and establish your career in...
-
Regulatory Affairs Manager
5 hours ago
United Kingdom Reed Specialist Recruitment Ltd Full timeHead of Regulatory Affairs (Healthcare) Location: North-West, UK Full time & permanent position Onsite 3-4 days per week Reed Scientific are working with a global healthcare provider based in the North West of the UK, and are currently seeking an experienced Regulatory Affairs Manager to oversee and manage the regulatory affairs team. Main...
-
Regulatory Affairs Manager
2 weeks ago
United Kingdom Reed Engineering Full timeHead of Regulatory Affairs (Healthcare) Location: North-West, UK Full time & permanent position Onsite 3-4 days per week Reed Scientific are working with a global healthcare provider based in the North West of the UK, and are currently seeking an experienced Regulatory Affairs Manager to oversee and manage the regulatory affairs team. Main...
-
Regulatory Affairs Manager
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Regulatory Affairs ManagerRegeneron Ireland DAC is seeking a highly skilled Regulatory Affairs Manager to support our CMC development activities from a regulatory standpoint. The successful candidate will participate in cross-functional meetings, identify regulatory issues, and suggest strategies to mitigate risks.Key Responsibilities:Review...
-
Regulatory Affairs Manager
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Regulatory Affairs ManagerRegeneron Ireland DAC is seeking a highly skilled Regulatory Affairs Manager to support our CMC development activities from a regulatory standpoint. The successful candidate will participate in cross-functional meetings, identify regulatory issues, and suggest strategies to mitigate risks.Key Responsibilities:Review...
-
Regulatory Affairs Manager
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Regulatory Affairs ManagerRegeneron Ireland DAC is seeking a highly skilled Regulatory Affairs Manager to support the development and approval of gene therapies.Key Responsibilities:Participate in cross-functional meetings to discuss program-specific regulatory strategies.Identify and mitigate CMC regulatory risks.Review regulatory filing...
-
Regulatory Affairs Manager
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Regulatory Affairs ManagerRegeneron Ireland DAC is seeking a highly skilled Regulatory Affairs Manager to support the development and approval of gene therapies.Key Responsibilities:Participate in cross-functional meetings to discuss program-specific regulatory strategies.Identify and mitigate CMC regulatory risks.Review regulatory filing...
-
Regulatory Affairs Manager
3 weeks ago
United Kingdom Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeCompany Overview: As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products. To support our expanding international operations, we are looking to hire a skilled Regulatory Manager to oversee our regulatory affairs and ensure compliance in the United...
-
Regulatory Affairs Manager
3 weeks ago
United Kingdom Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeCompany Overview:As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products. To support our expanding international operations, we are looking to hire a skilled Regulatory Manager to oversee our regulatory affairs and ensure compliance in the United Kingdom.Job...
-
Regulatory Affairs Manager
7 days ago
United Kingdom Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeCompany Overview:As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products. To support our expanding international operations, we are looking to hire a skilled Regulatory Manager to oversee our regulatory affairs and ensure compliance in the United Kingdom.Job...
-
Regulatory Affairs Manager
6 hours ago
United Kingdom Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeCompany Overview: As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products. To support our expanding international operations, we are looking to hire a skilled Regulatory Manager to oversee our regulatory affairs and ensure compliance in the United...
-
Regulatory Affairs Consultant
1 month ago
United Kingdom Fusion Pharma Limited Full time*No recruiters please*Regulatory Affairs Consultant, Fusion Pharma THE COMPANYWe are Regulatory Affairs experts who specialise in the UK and EU pharmaceutical industry, we offer a bespoke consultancy service to our clients. Our first priority is to have a positive workplace culture where employees feel respected and valued. To achieve this, we only hire...
-
Product Stewardship Specialist
3 weeks ago
united kingdom VRS Regulatory Full timeGlobal household name speciality chemical companyResponsibility for National and Regional regulatory compliance Diverse business units – complex aqueous mixtures and substancesBecome a regulatory subject matter expert This will be a highly diverse role; typical duties include answering complex customer regulatory enquiries, researching/impact assessing...
-
Senior Manager/Director of Regulatory Affairs
6 hours ago
United Kingdom Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeCompany Overview: As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products. To support our expanding international operations, we are looking to hire a skilled Regulatory Manager to oversee our regulatory affairs and ensure compliance in the United...
Regulatory Affairs Manager
2 months ago
We are looking to speak to experienced Regulatory Affairs professionals who are seeking their next challenge. Our client is a dynamic, fast growing business with a entrepreneurial passion and a pipeline to match
Working in a close knit team of five, the Regulatory Affairs Manager’s role is to take responsibility for and execute various regulatory activities related to EMEA and UK region. This is not a managerial position.
*** You must have experience working within generics ***
Responsibilities include:
- Preparation, submission, and management of variation applications to agreed timelines.
- Manage and submit Renewals and PSURs in line with specified timelines.
- Preparation, submission, and management of approvals of National, Mutual Recognition, Decentralised Procedure applications in the region.
- Preparation and maintenance of the product information (SmPC/PIL).
- Management of all regulatory activities related to the UK and EU markets (including artwork approvals, maintenance of Manufacturer’s / Importer licence (MIA) etc.)
- Record data in relevant regulatory database.
- Maintenance of a regulatory archive (dossiers, documents, electronic media).
- Preparation of regular reports for regulatory and management purposes.
- Support to the various business functions (e.g. portfolio, out licensing, launch management)
- Proactively contribute to the strategic development of the regulatory function as a whole and hence to the successful development of the commercial operations in Europe, Middle East and Africa.
- Ensure development of procedures for compliance purposes
- Manage or guide more junior staff when required.
Qualifications and Role Requirements
- Life Sciences degree or equivalent is essential.
- An in-depth understanding and experience of EU regulatory requirements including marketing authorisation submissions and maintenance activities on a European level.
- Experience working in a UK affiliate is a requirement.
- Experience in other non-EU markets in the region is an advantage.
- Proven success in the timely management of regulatory approval procedures
- Ability to work to deadlines and able to successfully prioritise numerous projects simultaneously.
- Ability to work independently as well as within a team
- Excellent verbal and written communication skills.
- IT skills at an advanced level (Excel and other MS Office tools, various Regulatory Affairs Information Systems such as eCTD publishing tools, databases and tracking systems, CESP, MHRA portal, etc.)
- Ability to work in a multicultural environment.
On offer:
- Competitive salary banding plus Bonus – on target achievement of PMP up to 12%
- 28 Days annual leave plus bank and public holidays
- Life assurance – x4 annual salary
- Private medical insurance – self and spouse
- Pension 7.5% contribution from employer – minimum employee contribution 0.5%
Pro4orm People Ltd is acting as an Employment Agency in relation to this vacancy. Pro4orm People Ltd will only be able to contact successful applicants within 5 working days. We may, however, contact you regarding other potential roles of interest. By applying for this position you will be agreeing to our Terms and Conditions, and Privacy Policy which can be found on our website
