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.
Qualifications
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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