Title:  RAPV Affiliate Team Lead

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.

Working Environment and Location

This position is based in Mexico City (Santa Fe area) and will require on-site work in a hybrid set up.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and Scope

Leads Regulatory Affairs & Pharmacovigilance (RAPV) at affiliate level with line management responsibility for the RAPV team. Acts in alignment with global functional and local Brand Team objectives and priorities with overall responsibility for all products in scope of the affiliate(s).

Responsibility for adequate RAPV affiliate team capacity, capability and prioritization management to ensure:

• Development and execution of the affiliate RAPV strategy, planning and objectives.
• Effective operation of the PV system and enabling the local PV contact person / local Qualified Person for PV (L-QPPV), as applicable, to fulfill their duties.
• Compliance with Astellas policies / procedures and relevant laws / regulations / guidelines as well as continuous improvement of the affiliate Quality Management System, including effective regulatory intelligence and change management.

Represents Astellas towards local Health Authorities and pharmaceutical industry associations, where appropriate. Acts as single point of contact for headquarters and key stakeholders (e.g., Commercial and Medical Affairs, Market Access & Pricing, Quality Assurance, Supply Chain) and represents RAPV in the affiliate Management Team (MT). 

Role and Responsibilities

General

• Identifies and implements ways for RAPV to contribute to compliance, growth and profitability of the affiliate. 
• Contributes to the development and implementation of global, regional and local RAPV long-term, mid-term and annual strategy and plans.
• Aligns affiliate RAPV strategy and planning of activities with local Brand Teams, including relevant extended members.
• Anticipates fluctuating workload and ensures adequate resourcing and prioritization.
• If applicable: Ensures that locally mandated roles (e.g., responsible regulatory/technical/pharmaceutical person, national safety contact) are facilitated and executed as required by local legislation/guidelines.
• Ensures effective collaboration between affiliate RAPV, local Health Authorities, headquarters, the affiliate Brand Teams and MT, and other key stakeholders. Liaises with the EU-QPPV / L-QPPV (periodic and ad-hoc), as applicable, to enable the EU-QPPV / L-QPPV to maintain PV system oversight and fulfill its duties.
• Where required, ensures a local mechanism is operational for appropriate handling of potential safety issues, timely communication of information that requires notification to a local Health Authorities as well as timely responses to local Health Authority requests.
• Manages the affiliate RAPV budget in a cost-efficient manner.
• Ensures effective RAPV business continuity arrangements and third party life-cycle management.
• Participates in due diligence for potential new product acquisitions, as needed. Ensures RAPV support for local Business Partners and RAPV responsibilities are correctly described in the relevant agreement(s).

People and organization management

• Promotes a culture that models ethical and compliant behavior, and matrix/cross-functional collaboration.
• Leads successful recruitment and effective performance and personal development management to establish and maintain a high performing RAPV team.
• Ensures availability of a sufficient number of competent and appropriately trained affiliate RAPV staff to conduct all RAPV related matters at affiliate level, including adequate backup arrangements.
• Ensures provision of Product Safety Awareness training of third party personnel for PV-related services, as applicable.

Continue:Role and Responsibilities

Operational excellence and compliance  

• When applicable: Ensures timely and high quality RAPV input for business cases (e.g., new registration).
• Attends and facilitates key meetings with local Health Authorities to support development and execution of the RAPV strategy.
• Ensures alignment of the planning of RAPV activities with headquarters and applicable stakeholders.
• Ensures product safety information is adequately collected from all applicable sources and that the Global Safety Database is used to record and manage this information accurately and completely at affiliate level.
• Safeguards timely and high-quality management (e.g., change control, preparation and submission to local Health Authorities) of RAPV dossiers and records in accordance with applicable standards.
• Ensures adequate communication about local RAPV submissions and outcomes (e.g., approval, deficiency), with internal and external stakeholders and databases maintained up-to-date accordingly. 
• Supports proper implementation of RAPV submission outcomes, including preparation of artworks (printed packaging components) and communication of Product Information to relevant stakeholders.
• Makes sure that RAPV review and approval of (abbreviated) prescribing information and promotional materials is in accordance with Astellas standards and country legislation. 
• Ensures clearly defined roles and responsibilities and adequate management of local activities associated with ongoing safety evaluation (e.g., signal detection, periodic reporting), Risk Management Plans and additional Risk Minimization Measures.
• Ensures ‘audit/inspection readiness’ with processes and procedures well-documented. Adequately manages issues and non-conformances. Implements new initiatives, tools, systems, processes and procedures in cooperation with headquarters. Coordinates RAPV representation and support for GxP audits/inspections to ensure that verbal and written requests for information are addressed timely and correctly. 
• Enables up-to-date input for the (L-)PV System Master File (PSMF).
• If applicable: Ensures RAPV review and support for tendering processes.

Essential Qualifications

• BA/BS Degree in Pharmacy, Medical or other Life Science, or equivalent by experience 
• Minimum of 5+ years relevant experience in RA, PV or combined PV/RA/QA role 

Preferred Qualifications

• Experience with people management
• Relevant external pharmaceutical (professional) training with an advanced professional degree 

Benefits

Careers | Astellas

Why Astellas

• 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. 

Learn more at Astellas.com