Description
One of Volts global pharmaceutical clients are seeking a Regulatory Executive to join their offices in Berkshire.
Role Responsibilities
Responsible for all tasks associated with managing life cycle submissions. The position is responsible for providing submission strategy for all registration activities within the countries under responsibility and driving all activities required for timely and effective submission and approval of changes with Boards of Health.
Major Duties:
* Provide submission strategy for execution of life cycle submissions associated to management of
CMC changes originating at manufacturing sites.
* Provide regional/local management of life cycle submissions in markets under responsibility,
including: Market Application amendments, variations, renewals, supplemental submissions.
* Coordinate with the Regulatory Process & Systems Support and Publishing team for the generation
of the submission ready components required to support life cycle submissions.
* Assemble life cycle submissions for markets under responsibility and coordinate timely and effective submission of changes to the Boards of Health.
* Ensure that the CMC change management electronic systems are updated and maintained in
alignment with the regulatory information submitted/approved externally by a Board of Health or
internally by the appropriate functional area.
* Manage timely responses to Board of Health questions resulting from life cycle submissions in
markets under responsibility.
* Compliance with Department and Company Standard Operating Procedures (SOP's) relevant to the
position.
* Assist Regulatory Affairs staff with other regulatory activities as needed.
* Interaction with plants and Division personnel in relation to regional regulatory conformance
activities.
Qualifications
Essential Criteria for the role:
* Bachelor's degree or equivalent qualifications in Chemistry, Pharmacy or a related life science field.
* Experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or
Compliance.
* Strong knowledge/background of Regional CMC.
* Experience with CMC submissions
Desirable criteria:
Experience in negotiation with Regulatory Authorities
Experience in non-EU submission requirements