Description
Regulatory Affairs Manager- 12 months contract UK- home basedGlobal pharmaceutical company is looking for experienced regulatory affairs expert to support projects in the development and post marketing stage.
Your responsibilities:
* 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.
* 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 Strategy and Execution Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within assigned portfolio in compliance with global filing plans and local regulatory requirements.
* implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
* Provides content guidance for regional regulatory documents and meetings in accordance with strategy
* Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan)
* Manages in the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
* Supports regional label negotiation activities
* participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
Requirement:
Excellent knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country.
Strong experience / knowledge of global procedures CTA/ MAA (variations / extensions)
This is 12 months contract home, inside of IR35 offering excellent hourly rate
Michael Bailey International is acting as an Employment Business in relation to this vacancy.