Sr. Manager, RPR, LATAM Business Partner
The Opportunity:
====================
Reporting to the Regulatory Affairs, Pharmacovigilance Lead, as the Sr Manager, RPR (Regulatory Partner Responsible), LATAM Business Partner you will focus on partner management and oversight of partner activities. Your key interactions will be with Local partners, Local industry association(s), In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA (Global Regulatory Affairs) Regional team.
_This is a hybrid role, requiring three (3) days of onsite work weekly. #LI-hybrid_
The Role:
=============
_Strategy (execution) & (partner) management_
- Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; perform due diligence, monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly; conduct risk assessments of partners to identify potential risks and vulnerabilities.
_Strategy (execution) & (partner) management_
- Manage inventory of partners and ensure synergies are identified and implemented.
- Conduct periodic assessments and audits of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities. Act as RA representative in audit/inspection and ensure readiness and timely CAPA closure in alignment with other functions.
- Act as point of contact for escalations and issue resolution related to partner activities.
- Align closely with GRA for contract management purposes to ensure regulatory standards are met.
_Strategy (execution) & (partner) management_
- Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations.
_Strategy (execution) & (partner) management_
- Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs.
_**Strategy (executi...
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.
Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis.