Lead, Regulatory Affairs Cmc Biologics

**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**

This position plays a key role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions.

This position is responsible for development and successful execution of CMC regulatory strategy (e.g., CMC strategy/planning for NMEs and NBEs) in close collaboration with Global Regulatory Lead, and writing of CMC documents (e.g., CMC modules, IND/IMPD CMC documentation), for assigned products.

**Essential Job Duties**

Independently acts as CMC regulatory lead or Deputy for complex projects/products and/or participates in non-product or overarching related activities.

Prepares and reviews with mínimal supervision, CMC documentation of e-CTD Quality modules, IND/CTA/IB and briefing documents for Health Authority (HA) consultation meeting for assigned products.

Acts as CMC regulatory expert by global project and product teams/task forces and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions.

Member of global project teams/task forces which require expert interpretation of applicable EMA/FDA/PMDA/ICH/Global regulations to ensure CMC compliance within the organization.

Provides CMC regulatory expertise for New Product Planning and Licensing due diligence activities.

Manages the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with local and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global Health Authorities.

Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.

Defines and implements regulatory strategies and priorities for; global and regional registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control

processes and related compliance issues in collaboration with local, regional and global stakeholders.

Oversees submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs.

Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.

Provides regulatory guidance for compendial issues of Ph.Eur., USP and JP and monograph preparation.

**Required Qualifications**

BS in Chemistry/Pharmaceutics or equivalent degree