Regulatory Affairs Manager

About the job
IQVIA is looking for a Regulatory Affairs Manager for our client.

Job Description

Registration and maintenance of product registrations in project countries
Compliance with company policies and regulatory requirements pertaining to the registration of veterinary medicines in the specified countries
Manage and control product printed packaging materials
Review and approval of promotional materials
Identifying and help scoring potential future innovation for the specified project.
Functions, Duties, Tasks:

Interaction with Competent Regulatory Authorities, Local technical representatives and Consultants on Product Registrations and Associated Legislations:

Own the interaction with the Authorities, LTR’s and consultants by taking ownership of the interactions
Permanent mapping of the Authorities and diamond coordination between our client and the Authorities

Regulatory Maintenance of Existing Product Marketing Authorizations:

Ensure product regulatory compliance by submissions of MAT’s, variations, renewals, notifications, commitments etc.
Prepare the Regulatory submission package (Cover letter, fees, etc.)
Work with LTR’s and consultants to submission and follow up steps.
Keep permanently updated on relevant regulations in the territories.
Provide local requirements to CMC/Manufacturing for Manufacturing maintenance
Provide local requirements to global RA/R&D for new product registrations

Regulatory Database:

Ensure compliance to procedures and systems to maintain proper regulatory records
Ensure accuracy of information kept in Regulatory Information Systems for the territory
Coordinate appropriate electronic and/or physical archiving

Affiliate Label Responsible Person (ALRP):

Ensure regulatory compliance of printed packaging materials (PPM)
Prepare and submit PCAP (if change is initiated by RA)
Review artwork
Accountable that label is in compliance with current regulations for each country

Promotional materials:

Ensure content of promotional materials is in compliance with existing regulations
Verify that the content of promotional materials is in compliance with existing licenses/SPCs and local labelling
Review and approve all materials (including presentations and training) in the system from a regulatory and technical perspective.
Ensure that the submission pathway for all promotional materials to the Authorities for approval is followed where applicable

Regulatory Inputs:

Advise business by providing regulatory inputs to commercial strategies in the territory
Communicate relevant regulatory changes and impacts to the commercial organization
Establish and maintain an updated system to communicate changes in the SPC to the commercial organization in the territory
Provide regulatory advice for customer communications in the territory

Representation of our client in National Industry Associations and NGO meetings, if applicable:

Shape the local regulatory environment in order to advance the project Shared Value mission
Represent our client and defend company interests in national industry associations
Align participation strategies with our client representatives at regional associations

Innovation Support:

Ensure Innovation support, both to local (within the project area), and global (R&D and Regulatory) where applicable.
Monitor local registration trials when needed, complying with all needed policies and legislation.

New registrations (non – EU):

Obtain new registrations in the territory.
Compile requirements in the territory
Submit Vault RIM requests to obtain the documentations needed
Write local submission documents (cover letter, application forms etc.)
Translate dossier and labelling as required
Ensure payment of local fees
Work with LTR and consultants to submit dossier and follow up until approval with the Authorities
Coordinate with commercial organization in the territory for milestone dates towards registration and launch

Minimum Requirements:

Applicable Tertiary qualification
Registered with the applicable Professional Board
Recommended at least 5 years in Pharmaceutical Industry, with at least 2 years’ experience in Quality Control and/ or Product Registrations as well as Technical field experience

Apply via :

www.linkedin.com