Current Positions Available

Please select vacancy category to search for:

1788 Surrey	Regulatory Affairs Executive Regulatory Affairs Labelling Manager required with responsibility for the management of labelling processes on assigned products across countries in the EU. This role will monitor EU labelling regulations, overseeing product labelling requirements/deliverables across EU company offices as well as serve as a region/site point of accountability for EU “above country” regional labelling processes/requirements. This role focuses on and is responsible for all labelling related activities designated as “above country”, primarily for products covered under the EU National registration procedure (though sometimes MRP or de-CP as well) and delivering product SmPC text in applicable formats to support the submission and approval of company products marketed in the EU. The EU Labelling Manager interfaces with and supports the product Global Labelling Manager, the EU Regulatory Strategist and EU PCO Regulatory Manager in the management of labelling text through appropriate processes and systems to assure timely delivery and ultimate approval of company product labelling in the EU. The EU Labelling Manger may participate in Global Labelling Sub-Team meetings, if requested, and is responsible for the logistical aspects of implementation of SmPC text in the EU consistent with Global objectives. Additionally, the EU Labelling Manager acts as a subject matter expert on EU labelling requirements and participates in the development of new tools, technologies and processes that support global label development by assuring feasibility and usability in the EU (e.g. GDMS, PIM, and/or central Translation Memory systems. This role may suit someone looking to work a couple of days from home. Previous experience in a similar role will be essential. Vacancy Reference Number: 1788
1789 Surrey	Regulatory Affairs Executive Regulatory Affairs Executive urgently required with experience of generic licence applications and post-licensing maintenance activities and sound knowledge and experience of the following activities; labelling and CMC variations, updates to PILs and packaging, experience in managing National (UK and Ireland) and MRP/DCP licences. Ideally candidates will have experience of using Sentinel and RIO. Initially this is a short-term assignment. Vacancy Reference Number: 1789
1790 Surrey	Regulatory Affairs Executive Regulatory Affairs Executive urgently required to support Generics project assisting with MA TRANSFER. Candidates MUST have experience of post-licensing maintenance activities and sound knowledge and experience of the following activities; change of ownership applications, updates to PILs and packaging, interactions with MHRA and IMB. Experience of using Sentinel and RIO would be an advantage. Vacancy Reference Number: 1790
1792 Surrey	Regulatory Affairs Executive Regulatory Affairs executive required with experience of post-licensing maintenance activities within Ethical Pharmaceutical Industry (prescription only medicines) and sound knowledge and experience of Clinical and CMC variations, updates to PILs and packaging, variations to align SPC with Core Data Sheet, submission of PSURs and CSPs, and experience in managing National (UK and Ireland) and MRP licences. Ideally the candidates will also have experience of using Sentinel and RIO. Vacancy Reference Number: 1792
1799 Berkshire	Regulatory Labelling Coordinator Labelling Coordinator required to raise and coordinate change controls within labelling change control system (Trackwise) and manage artwork and labelling text files in EDMS (or GDMS) repository. In this role you will be responsible for assisting with artwork change control and records within labelling and packaging system or replacements related to license transfer activity. Vacancy Reference Number: 1799
1800 Berkshire	Regulatory Labeling Specialist Regulatory labeling specialist required for text and artwork change control within labeling and packaging system including coordination of translations for linguistic review, supervision of product labeling changes, and assisting manager with initiatives. In addition you will provide labeling expertise on registered products. Ideally candidates will have a degree level education; experience at a European level, be able to show established regulatory expertise - specific labeling experience would be an advantage. An additional European language and some project management experience would be an advantage Vacancy Reference Number: 1800
1801 Surrey	Regulatory Scientific Adviser We are currently looking for a Scientific Adviser with pulmonary vascular or cardio vascular experience to be responsible for ensuring that all materials delivered to countries by the pulmonary vascular disease teams accurately communicate product knowledge, and are appropriate for use, and meet general technical standards for European markets. Ideally candidates will have a degree in Science, Pharmacy or Health Sciences, have solid experience in healthcare, pharmaceutical or a related field, be a highly motivated and proactive scientist with knowledge of medical marketing, clinical research and regulatory requirements. In addition, experience of promotional review and sign-off in Europe, of working with cross-functional teams and the ability to critique, evaluate and communicate scientific data will be an advantage. Vacancy Reference Number: 1801
1809 Berkshire	Regulatory Affairs Executive Regulatory affairs executive urgently required to create CMC sections of Emerging Market initial submissions for established and/or new products and pass to the Product Strategist by the required date, and to respond to CMC-related questions as part of the project team, by the required date. In addition, to use established systems (particularly web-based document management systems) to ensure global transparency of submitted and approved documentation. Ideally candidates will have a life science degree, and several years Regulatory Affairs experience in European and/or global market primary applications or similar. Candidates should be able to demonstrate a broad understanding of European legislation and both technical and procedural guidance; ICH CTD; applicable Module 3 guidance; and variations legislation and guidance at a European and/or global level. Good IT skills including use of Documentum based document management systems would be a distinct advantage. Vacancy Reference Number: 1809

All of these positions require excellent written and verbal skills, good organisation and attention to detail. RDL offers a comprehensive range of benefits including a highly competitive salary, pension and private health schemes, substantial bonuses and (where appropriate) company cars and mobile phones.

Please call us on 01962 860666 or send your CV to:

RDL Scientific, 13/29 Business Centre, Hyde Street, Winchester SO23 7TA.

Confidential Fax No. 01962 867386

Email : whill@rdlscientific.com

	Who we are
	Areas of Work
	Recruitment
	Why Us?
	Vacancies
	Contact Us
	Site Map

RDL Scientific

Regulatory Affair Job - Regulatory Job

Current Positions Available