Regulatory Affairs Advisor Medical Devices East Anglia £28,000 £33,000 per annum + BenefitsSRG are looking for an experienced Regulatory Affairs Advisor with knowledge and experience...
To oversee the preparation and compilation of MAA's ensuring all documentation to the highest standard whilst adhering to all compliance guideline.
Major Duties and Responsibilities:
- Oversee all regulatory affairs related project management of Marketing Authorisation Application (MAA) submissions and monitoring status of applications
- Provide cross functional teams with regulatory input in order to obtain timely approvals and contribute to the product development and regulatory strategy planning.
- Authoring of regulatory submission documents (Modules 1,2 and 3)
- Compilation of full initial application dossiers for assigned projects in accordance with EU and US standards, as applicable.
- Working with CMS document authors from other internal functions and external providers to ensure compliance with regulatory and company guidance / template specifications.
- Co-ordination and preparation of responses to Regulatory Agency queries / deficiencies via close cooperation with other involved functions and liaison with Regulatory Agencies where required.
- Participating in project launch meetings, review meetings and project team meetings as required. Liaise with CROs to ensure timings and compliance of clinical trials
- Providing project specific regulatory strategic advice, technical expertise and coordination oversight
- Prepare, review and maintain knowledge and understanding of SOPs and assist in the effective implementation of the MAH's Quality Management System.
- Build business awareness of local regulatory requirements in the EU and international markets and provide regulatory advice, guidance and support to project teams, as required.
- Life Science Degree. Master's Degree in Pharmacy or other similar Life Science discipline preferred
- Extensive experience within Regulatory Affairs within the pharmaceutical industry, including directly dealing with regulatory agencies.
- Exposure to eCTD format and electronic submission gateways is preferable.
- Experience in the following would be advantageous - Inhalation dosage forms, Generic products, EU MRP/DCP submissions, US NDA/ANDA submissions.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.