- Implement the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.
- Ensure submission and approval of high quality regulatory applications within planned timeframes. Maintain or support maintenance of clear metrics for regulatory deliverables.
- Preparation and support of new applications to obtain marketing authorisations
- Voicing affiliate perspective and needs to global and regional regulatory contacts
- Ensuring timely responses to requests from support groups and/or regulatory authorities
- Maintaining marketing authorisations (timely submission of post-approval maintenance activities like renewals, variations and periodic reports)
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Regulatory Affairs Role - Hampshire, United Kingdom - Planet Pharma
Description
Role: Regulatory Affairs Role
Type: Contract
Location: Hampshire
Duration: 12 Month
We are currently partnered with a global Pharmaceutical company who are now looking for a regulatory affairs associate to execute the Regulatory Plan/objectives to ensure the success of new product registrations for an initial 12-month-long contract with the likelihood of an extension.
Primary Responsibilities:
Regulatory Plan Execution
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on or email me on: -
If this role isn't suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated Planet Pharma offers a competitive referral scheme so you will be rewarded for your help
About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
