- To ensure that the client acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products
- To ensure timely regulatory compliance with above approvals
- As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)
- Advising the GRT on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles
- May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. IMT, IBT, NAMT)
- Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
- Under general supervision participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy - includes contingency regulatory planning/risk assessment
- Region Specific Activities EU: Review and approve promotional and non-promotional materials for use in the region EM: Manage the product lifecycle for individual countries per national agency requirements EM: Work through the regional leads to manage distributor markets
- Working with policies, procedures and SOPs
- Knowledge of relevant legislation and regulations relating to medicinal products
- Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
- Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and international borders.
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Regulatory Affairs Manager - Uxbridge, Greater London, United Kingdom - Planet Pharma
Description
Job Description*Regulatory Affairs Manager - Remote/hybrid in Uxbridge - Global Biotech*
Location: Hybrid in Uxbridge (Can be homebased but will need to attend office when required)
Length: 12 month contract - Company have average tenure of 5+ years
Rate: Incredible rate
FTE: Full time
This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
The purpose of this role is:
Responsible for:
What you'll need:
Minimum Qualifications
If you would like to discuss this vacancy further or to discuss your career options in confidence, please 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 recognized 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.
