Regulatory Affairs Manager at IQVIA

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