Beschreibung
We have an exciting opportunity for a senior manager/ associate director to manage the local regulatory activities for portfolio of products in the United Kingdom.Your tasks:
Provide input to regulatory strategies for portfolio products in development, as well as for the approved products in terms of life cycle management.
In collaboration with global regulatory leads and advise on clinical trial strategy where needed, and possible national scientific advice if relevant.
Collaborate with Commercial, Medical Affairs, Business Operations and Management (such as BUL, Medical Director, GM etc.) to define regulatory priorities based on business opportunities and the affiliate's business objectives.
Responsible for all interactions with local Health authorities including health authorities meetings.
Accountable for regulatory compliance to local Marketing Authorizations (including RMP compliance)
Responsible for local review, implementation and tracking of implementation of the risk management plans (RMP) for the products.
Review and input to GRLs in case of labelling changes.
Local implementation and tracking of post-authorization follow-up measures as required beyond RMP commitments if relevant.
Regulatory submissions as needed by local requirements (e.g. educational materials; packaging material language exemptions if relevant; promotional materials as per local legislation; notifications to local HAs as needed).
Provide Training on specific regulatory requirements
Provides local regulatory environment intelligence and advises on expected regulatory hurdles and local specificities.
Approves promotional and non-promotional items and local press releases per the established local Advertising & Promotional local SOP.
Accountable for compliance with local legislation including transparency requirements on interaction with HCPs, internal compliance policies in collaboration with Medical Director/Compliance Champion - e.g. acts as local compliance committee coordinator.
Requirements:
Minimum 7 years work experience in regulatory affairs in the country or region assigned
Strong knowledge of local regulatory environment and excellent understanding of all stages of drug development, including pre-approval and marketed compounds.
Proven track record of effective collaboration with health authorities in gaining approvals and defending approved products.
Ability to build team relationship and collaborate in a global team environment at all level of the organization.
Strong interpersonal communication and leadership skills.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.