Regulatory Affairs Specialist, (Unlicensed Medicines) job vacancy - apply online at ujob.co.uk
360262
Accountabilities/Responsibilities:
-Ensure accurate daily notification to the relevant regulatory bodies of products to be imported and obtain appropriate approval in a timely manner in order to meet patient needs.
-Maintain an excellent working relationship with key personnel at the MHRA and other relevant regulatory bodies to ensure prompt and effective resolution of any regulatory queries
-Gather and interpret new legislation at its formulation, consultation and transitional stages and be able to analyse and advise on the potential impact, positive / negative on company and its operations
-Accurate maintenance of product database related to notifications, including doctor\'s letters, acknowledgements and individual formal documentation and objections
-Ensuring that the company Regulatory inbox is regularly and effectively maintained so that enquiries meet with a timely response and information acted on accordingly.
-Communication with counterpart RAS to ensure that tasks are completed and relevant handover of ongoing work as appropriate. Inter-departmental communication regarding any regulatory queries relating to company business
-Researching EMEA or ROW and local Competent Authorities websites for information regarding regulatory changes paying particular regard to MLX\'s and equivalent documents
-Researching and analysing journals for information with regard to local industry interpretation of new or imminent legislation
-Building relevant and effective relationships with local regulatory authorities and competent authorities
-Compiling executive summaries and SWOT analysis of reviewed legislation
-Compiling and maintaining regulatory resource database/ Library
-Contributing to Country profile documentation
-Attending relevant conferences, seminars and forums .
-Close liaison with QA to build complaint QMS
-Weekly doctors letter review
-Contributing to RQM strategy as required
Essential Skills & Capabilities:
-Proven established ability and knowledge of Pharmaceutical Regulatory Affairs having focused on ROW / European regulations
-Proven capability of successful working relationships with related regulatory bodies
-Proven ability of interpreting legislation to meet the commercial needs
-Excellent communication and interpersonal skills
-Excellent attention to detail
-Degree or equivalent in a “Life Science”
-High computer literacy in MS office & sales order processing systems
£35000.00 p/a
Ella Popowicz
Always mention ujob.co.uk when applying by phone or post !
0207 255 6665
Medical Scientific
1st IT People Ltd and 1st Pharma people
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