Regulatory Affairs Officer - Type IA, Type IB, Type II, BSVs, Renewals, PIQ, BROMI and MAH Transfers
- Employer
- Mosaic Regulatory Solutions
- Location
- Home Based / Midlands
- Salary
- Negotiable
- Start date
- 14 Sep 2022
- Closing date
- 14 Oct 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Role: Regulatory Affairs Officer - 1 years experience ( must have some eCTD experience ) Post approval work and eCTD work
Location: Warwick/Home based
Salary: to £30,000
This innovative company is a private, family owned, independent UK based generic company, wishing to recruit a Regulatory Affairs Officer to join their growing team, on a permanent full-time basis reporting to the Regulatory Affairs Manager.
Key responsibilities will include: • Preparation and submission of documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II, BSVs, Renewals, PIQ, BROMI and MAH Transfers/COAs • eCTD publishing and validation of both new applications and post-approval applications for the company portfolio of products • Preparation and submission of Technical/Site Transfer Applications • Assisting with the preparation of UK and European Marketing Authorisation Applications • Maintaining up-to-date knowledge of national and European guidelines/legislation, rectifying issues of non-compliance where required. • Close liaison with various other departments, such as Technical/Quality, Medical Information and Pharmacovigilance, with a focus on anticipating and mitigating regulatory risks. • Ensuring compliance with all internal regulatory processes, in readiness for both internal and external audits. • Ensuring compliance with the regulations of the Medicines and Healthcare products Regulatory Agency (MHRA) & other Competent Authorities within the EU • Using a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information & data • Performance of other tasks or assignments, as delegated by the Regulatory Affairs Manager • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget • General regulatory administration duties and compliance requirements • Management of artwork generation, including regulatory and printer proof review. • Effectively utilising the company’s internal Change Control Process • Compilation of departmental SOPs Person specification / competencies • Minimum of 3 years’ experience in Pharmaceutical Regulatory affairs • Experience with compilation and publishing of applications into eCTD • Excellent attention to detail • Good IT skills/knowledge • Good organisational skills • Good communication skills • Pro-active attitude and able to work on own initiative as well as part of a team • Ability to prioritise different workloads/multi-task • Personal responsibility for ensuring a high standard of work • Ability to identify different and relevant sources of information relevant to the role
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Company
Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.
Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.
We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.
Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.
Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.
- Website
- http://www.mosaicreg.co.uk/
- Telephone
- 07951 082482
- Location
-
Blackheath
London
SE3
GB
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