Title:  Regulatory Affairs and Pharmacovigilance Associate, Mexico

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. 

Location and Working Environment

• This position is based in Mexico and will require on-site work.  The hybrid working arrangements are set per Affiliate and incumbent is expected to adhere to local guidelines. May require participation in inspections, vendor oversight and cross-functional meetings; operates in a collaborative office environment and interacts regularly with global/regional RAPV. May be required to participate in the affiliate 24/7 availability rota for urgent safety issues and may perform additional GxP or QA support activities as business needs require.

Purpose and Scope

To support execution of regulatory and safety strategy & activities for new Marketing Authorizations (MAs) and Life Cycle Management (LCM) of MAs in the affiliate territory, including contact with and submissions to the local Health Authorities (HA).

Submissions may include, but are not limited to, initial Marketing Authorization (MA) Applications, renewals, variations, import permits, ICSRs, PSURs, RMPs, DMF, GMP / Company registration applications of manufacturing sites, promotional materials and notifications, or any other submission that requires to be presented to the local Health Authority.

Responsible for acting as the back-up of the local Drug Safety Officer (DSO) and its related duties.

To collaborate on excellence in local Pharmacovigilance (PV) and regulatory compliance by maintaining local RAPV operations and quality documentation and supporting compliance with local and regional RAPV regulations and Astellas policies/procedures and relevant laws/regulations/guidelines.

Role and Responsibilities

Regulatory strategy and compliance

• Monitor, assess, apply, and communicate local regulatory intelligence with relevant global & regional stakeholders and within the affiliate. Update Regulatory Intelligence databases.
• Perform local regulatory tasks to support the execution of the regulatory strategy for new MAAs and LCM activities.
• Under supervision, prepare local submission documents, make submissions to the local HA, and follow up as needed.
• Contribute to the assessment and implementation of regulatory changes, following the applicable Change Control procedure.
• Initiate (as applicable), review and approve Product Information (PI) i.e., Summary of Product Characteristics (SmPC), abbreviated PI (aPI), PI Leaflet (PIL) & additional Risk Minimization Measures (aRMM), and artworks.
• Communicate RA milestones and outcomes to the relevant stakeholders, including internal and external systems. Perform data entry in relevant databases and trackers.
• Make the approved SmPC or/and PIL available for internal and external use.
• Support and/or participate in GxP inspections by local HA, as applicable.
• Support execution of local laboratory testing of products required for registration purposes, as applicable.
• Support affiliate tenders, Import license process or else, as applicable.
• As applicable, perform and support GxP tasks.
• Maintain training compliance.

Promotional materials

• Review promotional materials in line with applicable requirements and Code of Conduct.
• Work on project teams to implement improvements & update SOPs.
• Understand and interpret scientific data and make recommendations.
• Submit promotional activities to the HA, as applicable.

Pharmacovigilance

• Act as backup to the local Drug Safety Officer (DSO) and deputy for the local Qualified Person for PV where applicable, supporting the RAPV Affiliate Lead, DSO in PV objectives and any activities that ensure the business continuity of the RAPV department. These activities may include and are not limited to:
• Receive and manage safety information from all sources (PV mailboxes, medical information, HAs, literature, patients/HCPs) and ensure emails and safety reports are handled in a time-appropriate manner.
• Process safety information per procedure, enter data into the Global Safety Database (GSD) and perform applicable reconciliations with required accuracy and timelines.
• Coordinate and manage relationships with PV vendors, ensure timely intake/submission of ICSRs, perform reconciliations and quality checks, and demonstrate leadership when working with external vendors.
• Perform local literature review and local signal/aggregate monitoring activities as assigned and maintain availability for out-of-hours/24/7 rotation for urgent safety issues per affiliate rota.
• Maintain local logs, trackers and PV databases for oversight and audit readiness, develop/update local PV procedures, QDs and SOPs, and support PV agreements, vendor contracts, and inspection responses.

Continue: Role and Responsibilities

Stakeholder management

• Participate in local affiliates and other project team meetings as needed.
• Build and maintain collaborative relationships with internal functions (Medical Affairs, Quality, Marketing, Sales) and external stakeholders (HCPs, patients, HA), participate in local project teams and represent RAPV, as appropriate.
• Under supervision, communicate with HA.
• Begin to develop (or maintain) external relationships and network across other companies through participation of forums established by the local Trade Associations.

Continuous Improvement

• Contribute to local and global improvement projects, SOP updates, and support RAPV activities of any product lifecycle projects, as assigned.

Required Qualifications

• BS Degree in pharmacy, medical, life sciences, chemistry or similar.
• 4-5 years’ experience in Regulatory Affairs; minimum 3 years’ relevant PV experience or combined RA/PV/QA experience.
• Good knowledge of local RAPV requirements and ability to translate regulations into business needs.
• A technical expert with an in-depth understanding of aspects of the local RAPV processes and knowledge of related disciplines.
• Proficiency in local and English language.
• Excellent time-management and proven organizational skills.
• Strong aptitude to build knowledge and support a team.
• Demonstrable attention to detail.