A major pharmaceutical company is searching for a;
Senior Regulatory Affairs Manager.
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:
To ensure that the client acquires and maintains all the required licenses 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.
This role is responsible for:
. 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 Strategy and Execution Plans and manages regulatory submissions (eg clinical trial and marketing applications) for products within client’s 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 regulatory direction on regional regulatory mechanisms to optimize product development (eg expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan)
. Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
. Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy, includes contingency regulatory planning/risk assessment Management Supports communication/collaboration between direct reports who are regional leads and regional head for program issues requiring next level engagement
> More responsibilities included!
- Experience Leading one or more products, end to end
- Experienced developed the regulatory strategy
- Evidence of developing, leading and executing regulatory plans including PIPS, SA, ODDs.
- Oncology experience isn’t a prerequisite, but need to be able to demonstrate that you are a quick learner.
- Regulatory knowledge in regional legislation. Working with policies, procedures and SOPs
- Experience with national legislation and regulations relating to medicinal products
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Understanding of drug development Scientific/Technical Excellence
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Employment Type Contract
Advertiser Type Agency