Regulatory lifecycle management -CMC , Labeling, Post approval work - contract - REMOTE

Location
Home Based
Salary
Flexible
Posted
26 May 2021
Closes
25 Jun 2021
Ref
8778889
Discipline
Regulatory Affairs
Hours
Part Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Role:Regulatory Lifecycle Management

Contract - 1 to 2 days a week

Hourly rate - Negotiable

REMOTE based

 

Manage regulatory life cycle management activities worldwide, including but not limited to new drug

applications in additional territories, variations (CMC, labelling and administrative), renewals

and any pertaining pre-and post-approval activities (e.g. PSUR, RMP updates, post-approval

commitments, support of artwork creation and revision, change control process, regulatory

change assessment and support of compliant product release etc.) which may be

considered as regulatory relevant in one or several territories where client strives for

or holds a valid registration or Marketing Authorization for the above-mentioned products, in

collaboration with other regulatory groups and other line functions within client and

outside the organization (commercial partners, regulatory consultants) as per the processes

in place.

  •            Coordination of responses to Health Authority requests, both in the framework of a

regulatory procedure and adhoc

  •        Support and coordination of the maintenance of a core dossier as per the processes in place

and with the support of any required line functions or Subject Matter Experts within Client

  •        Authoring and updating of regulatory CMC documentation with the support of relevant

Subject Matter Experts within client, including:

• Quality Overall Summaries

• CTD Module 3 documents for initial Marketing Authorizations and CMC variations

• English version of country-specific documentation

Documents

• Briefing books for Health Authority interactions (e.g. pre-submission meetings) as

Applicable

  •        Ensure all documents which are part of a regulatory dossier are written on relevant Client

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