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
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.
This position can act as the subject matter expert (SME) for Regulatory CMC and works in close collaboration with stakeholders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners).
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 minimal 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
8+ years industry experience; pharma, CRO or academic with at least 3 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities in CMC related laboratories.
Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
Demonstrated track record for successful interactions with (global) health authorities related to CMC submissions.
Effective writing skills with the ability to meet regulatory requirements and standards
Ability to understand regulatory environment and apply concepts to perform job function
Preferred Qualifications
Advanced academic degree (Ph.D. or Pharm.D.), with relevant experience (5+ years) in product development in the manufacturing or regulatory field.
Advanced, interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment; able to manage complex projects by exercising independent decision making and analytical thinking skills; knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance; ability to work in cross[1]functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused; ability to adhere to strict project timelines; strong team player; good judgment and problem solving skills, with ability to identify, analyze, and resolve problems in a timely manner; fluent written and spoken English is required.
An additional experience next to small molecules, such as biological, vaccines, cell therapy or (medical) devices in a regulatory environment, or vice versa, might be a preference.
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.
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Category Regulatory Affairs CMC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
