Manager, Regulatory Affairs Pharmacovigilance

**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.**

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 who leads all PV activities in the affiliate - 50 % of their time is allocated to PV (can vary depending on workload).

Responsible for acting as back up to local Drug Safety Officer (DSO) and manage its related duties.

**Essential Job Duties**:
**Regulatory strategy and compliance RA**

Non-EU: Leads on national 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

EU: Contributes to the Established Markets regulatory strategy wherever possible and needed and communicates the affiliate input to regional RA, including advising on optimal labeling, EAP/CDx.

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 PI 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 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