Submission Manager, RA Publishing & Submissions

Submission Manager, RA Publishing & Submissions

Astellas Canada-

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.

Astellas Pharma Canada (APCA) is looking to fill vacant position – Submission Manager, RA Publishing & Submissions.

Purpose and Scope

• Responsibilities include managing the planning, preparation, submission and tracking of correspondence, applications and other structured data to regulatory agencies; identifying and ensuring adherence to relevant submission standards; and interacting with key personnel within the global RAPV organization to address procedural and operational complexities.
• The position also involves execution-focused interactions with regional health authorities and other Astellas functions such as Marketing Operations, Data Science, Supply Chain, Manufacturing and other areas within Research & Development.
• Submission Managers at this grade level are also expected to participate in process improvement and technology projects related to submissions.

Role and Responsibilities

• Understands how industry specifications/initiatives impact our processes and deliverables
• May train other staff members on systems and processes depending on areas of proficiency
• Identifies regulatory guidance documents, regulations, or directives that impact products and operations; notifies personnel within RAPV regarding their applicability and impact
• May contribute to creating training materials, authoring job aides and updating other documentation on our systems and processes
• May assist with certain business system support tasks for key systems including user and functional requirement definition, end user testing and technical infrastructure requirements
• Manages the planning, preparation, delivery and archiving of published submissions to regulatory agencies around the globe, commonly focusing on specific geographies
• Ensures adherence to relevant submission standards, regulatory pathways and regulatory strategies to facilitate efficiency of agency review
• Supports submission activities for affiliates and business partners commonly focusing on specific geographies
• Executes processes to promote electronic document and submission quality control
• Maintains strong working relationships with RAPV, members of Project Management and publishing vendors to set submission timelines and content plans
• Manages timely internal communication regarding regulatory filing status and other operational information related to assigned products
• May represent RAPV Operations on various project teams / task forces as a representative speaking to electronic document management, submissions management and dossier publishing

Essential Knowledge & Experience

• Bachelor’s degree (science or technology is preferred)
• At least three years’ experience in the pharma industry with some experience in a regulatory operations role
• Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed
• Ability to work independently with minimal direction and within project teams, committees, etc. to attain group goal
• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members
• Strong ability to communicate effectively in writing and verbally in English
• Ability to multi-task across multiple projects and deliverables
• High integrity to maintain confidential and proprietary information
• Ability to keep calm under pressure

Preferred Knowledge & Experience

• Advanced degree (e.g., Masters, PhD, etc,)
• At least four years’ experience in a regulatory operations role or similar
• Experience with managing IT systems or providing business operational support
• Experience using document management, submission publishing, registration management, labeling and/or change control systems
• Basic understanding of information taxonomies, master data management or other structured data concepts
• Basic understanding of data warehousing, data lakes and reporting/analytics platforms or concepts
• Proficiency in other language(s) – most common/useful are Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese

Salary Range: $80,000-$115,000 CAD annually per year (final compensation will be determined based on a variety of factors, including but not limited to proficiency levels and organizational equity considerations)

• The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time and national holidays
• Registered Retirement Savings Plan Program (RRSP)
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Wellness programs

Astellas may use artificial intelligence-enabled tools at various stages of the recruitment and selection process.

Additional information:

• This is a permanent full-time position.
• This position follows our hybrid working model. Role requires a blend of home and a minimum 1 day per quarter in our respective local affiliate office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
• 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.

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 RAPV Affiliates: International Markets

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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