At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. **What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.** Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation. **About Us:** We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma. **In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.** We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you. From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset. **Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.** **Description:** + To arrange the provision of regulatory expertise and execution of regulatory strategy and activities, including contact with and submissions to the local Health Authority (HA) and management of Product Information and artwork. + Submissions may include, but are not limited to, initial Marketing Authorization Applications and its associated submissions (including CTAs), post approval variations, PSURs, and notifications. + To ensure regulatory compliance with Astellas policies, regional/local regulations and the registered dossier including review/approval of promotional materials. + Support the Lead Pharmacovigilance (PV) or Drug Safety Officer (DSO) at the affiliate. 50 % of RAPV managers time is allocated to PV (can vary depending on workload) or RA. + Responsible for acting as back up to local Drug Safety Officer (DSO) and manage its related duties. + Manages assigned Pharmacovigilance (PV) tasks and responsibilities at affiliate level. Ensures high-quality PV record management and compliance with applicable policies / procedures, laws / regulations / guidelines and contractual agreements. Acts in close coordination with the Drug Safety Officer (DSO) and RAPV Affiliate Lead. May be assigned as and act as Deputy DSO, and as Deputy local Qualified Person for PV (L-QPPV) and/or local PV contact person backup, as applicable. **Essential Job Duties:** **Regulatory strategy and compliance RA** + Ensures timely preparation, submission and follow up of regulatory applications to ensure maintenance of marketing authorizations, including preparation of regional-specific documents. + Lead/Support regulatory submission strategy including advising on optimal labelling, EAP/CDx. + Supports global team in preparing responses to questions from Health Canada screeners and reviewers in consultation with local project teams within Health Canada’s specified timelines. Identify and resolves issues for responses. + Influences and negotiates regulatory requirements with Health Canada and Astellas for assigned projects + Communicates RA milestones and outcomes to the relevant stakeholders, including internal and external systems. Performs data entry in relevant databases and trackers. + Contributes to process improvement with regards to data management. + Regulatory Information management, including systems update internal and external. + Product Information (i.e., Product Monograph / aPI / PIL / aRMM) and artwork management. Provides advice to regional RA on label strategy. + Makes the approved Product Monograph (PM) or/and the leaflets, available for internal and external use. Advises on implementation tactics for Product Monograph updates. + Maintains training compliance and helps co-workers understand the impact of appropriate training. **PV: The responsibilities of a back-up or Deputy DSO furthermore include, but are not limited to:** + High-quality PV record management. + Develops/Supports the creation and maintains local procedures to ensure adherence to applicable PV requirements. + Provides adequate PV training as required. + Effectively works cross-functionally to ensure compliant and up-to-date PV-related contractual arrangements. + Adequately collects and manages product safety information from all applicable sources and ensures that the Global Safety Database (GSD) is used to record source information accurately, timely and completely at affiliate level. Maintains effective oversight of local / regional / global suppliers that manage this activity permanently or temporarily. + Ensures that safety information (Adverse Events) received from all sources (e.g literature search, Market Research, Patient Support, Digital Media) by the affiliate are collected, translated and forwarded to designated Regional Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards, as applicable. + Overseeing and monitoring compliance of case documentation, as applicable. + Periodically reviews local literature, as applicable. + Supports the distribution / submits aggregate reports such as Periodic Safety Update Reports (PSURs) to Health Canada, Investigators, as required. Manages local translations and creation of annexes and cover letters where required. + Supports the distribution / submits Risk Management Plans, where required with local translations (as required) and cover letter. Creation and maintenance of L-RMPs as applicable. + Supports timely implements additional Risk Minimization Measures, as applicable. + Manages local signal detection- and management-related activities. + Manages outsourced partners to ensure PV activities are conducted according to the relevant procedures, as applicable + Supports the creation and maintenance of locally applicable PV Quality documents. + Ensures filing, storage and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures + Request to have access to, and be aware of, the affiliate business continuity plan (for example system failure and other disasters) in relation to PV activities. Responsible for ensuring a local mechanism is in place for 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate. + Ensures timely and compliant management of locally required post-authorization studies, as applicable. + Ensures effective PV business continuity arrangements and PV-related third party life-cycle management. + Supports/Leads PV system audits, inspections and management of non-conformances and Corrective Actions and Preventive Action (CAPA) plans. + Appropriately handles potential safety issues as well as timely communication of information that requires notification to local Health Authorities and timely responses to local Health Authority requests. + Ensures up-to-date content for the (L-)PV System Master File (PSMF) **RA: Promotional materials** + Reviews/approves promotional materials with an in-depth understanding of code. + Ensures processes in place are efficient and risk-based. + Understands and interprets scientific data and make recommendations and informed decisions. + Provides input to above-country materials review. **RAPV: Internal stakeholders** + Provides strategic support and maintains close collaboration within global and regional RAPV groups and local affiliate. Participates in launch and brand teams and align RA activities with other departments. + Participates in local affiliate and other project team meetings as needed. + Leads local meetings and collaborates across affiliates to improve efficiency. + As applicable, performs GxP tasks (e.g., Quality Documentation PQR and CAPA review) and ensures inspection readiness. + Support QA lead and/or also act as Deputy DSO. **RAPV: External stakeholders** + Autonomously communicates with HA when required. + Ensures regulatory compliance and reputation. Develops and maintains professional relationships with relevant external contacts including the Health Authority and Trade Associations. + Monitors, applies and communicates local regulatory intelligence within regional RA and the affiliate. + Communicates and applies the regulatory strategy in the local affiliate. + If applicable: Coordinates regulatory activities performed by local business partners / RAPV suppliers, in line with the RAPV agreement in place. **Required Qualifications** + Bachelor’s degree in life sciences + Minimally 3-5 years RA and PV experience or relevant experience/exposure to RA or PV. + Knowledge of Regulatory landscape and procedures within the country/region, including directly dealing with regulatory agencies. + Good communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders. **Additional Information** Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process. Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation. _No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._ \#LI-SS Category RAPV Affiliates: Established Markets Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans