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Manager, Regulatory Affairs
Business Area Overview
The Europe & Canada (EUCAN) Business unit supports Takeda's mission at a regional level and as the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people.
Across the EUCAN BU, patients come first in every decision we make. We develop strategic partnerships which deliver value for society and create a culture within which our people can thrive and reach their full potential.
Our mission is to empower and enable our people to fulfill their potential by embracing diversity and creating a high-performance, collaborative working environment. In the EUCAN region integrity is one of our key values. We put patients, trust and reputation before business and this is one of the main reasons why our people choose to work here.
What makes a successful team member within EUCAN at Takeda?
I know that I need to work in a place where I can grow and be challenged, and what motivates me the most is to make a difference. I think what we offer here at Takeda truly helps patients. And it’s important to bring others along on that journey.Rebecca Yu VP of Patient Value & Access
Believe in your own ability to do the things you want to do. If you do that, things will happen.Heena Howitt Country Medical Lead Genetic Diseases
The faster we help someone get a true diagnosis of their underlying condition, the faster we can offer a treatment that can help them get back to living their life and improve their future outlookChristian Downton Business Unit Director Rare Metabolic Diseases
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Manager, Regulatory AffairsJob ID R0042417 Date posted Aug. 19, 2021 Location Toronto, Canada
Lead regulatory projects throughout the product development and approval process by developing, maintaining, and implementing proactive and innovative regulatory strategies. Ensure compliance with health regulations relevant to Takeda Canada and its products.
KEY JOB ACCOUNTABILITIES
- Complete quality submissions to Health Canada for assessment, ensuring timely approval with maximal opportunity for Takeda Canada and its products, while maintaining compliance. Interact with and respond to questions from health authorities. Liaise with internal departments and external experts in order to provide information to regulatory bodies.
- Accountable for environmental scanning and information management through the monitoring of domestic and international requirements. Maintain current knowledge of regulations, industry activities, product information and therapeutic areas.
- Follow standard operating procedures, policies and best practices to ensure consistency of procedures and compliance with regulations governing Takeda’s industry. Responsible for the review of regulations and the development of policies/practices to ensure that compliance requirements are met.
- Maintain efficient project management by preparing and updating required tasks and timelines, determining financial and human resource requirements and ensuring that projects remain on target. Communicate effectively with all departments at a management level regarding the project management timelines and tasks in order to develop and meet Departmental and Brand Team goals and timelines.
- Interact with health authorities to ensure that Takeda’s interests are raised and opportunities are optimized within the regulatory environment. Initiate meetings/discussions and participate and negotiate on behalf of Takeda with regulatory authorities at the meetings.
- Build relationships with service providers, Takeda corporate, Health Canada and consultants to ensure maximum cooperation and exchange of ideas and information. Ensure a base of mutual respect when negotiations are required.
- Create regulatory strategies for new products to maximize success in the registration process. Strategy includes building optimal labels, possible priority review justifications, submission timelines, consultation and involvement of external stakeholders as needed. Guide Global Regulatory Affairs with respect to submission strategy, needs and submission preparation to ensure Takeda Canada’s strategic needs are met.
- Provide regulatory expertise to Commercial Brand Teams and Development Teams, both locally and globally, to maximize the potential of submissions. Provide and make recommendations into regulatory risk assessment relative to the overall strategy.
- Review marketing/sales promotional brochures and advertisements and labels for regulatory compliance.
Occupational Knowledge and Skills
- Knowledge of health agencies (Canadian, European, and FDA) to ensure that Takeda Canada’s concerns are addressed, business opportunities are maximized and procedural guidelines are developed as required.
- Knowledge of Canadian governmental regulations (Food and Drugs Act and Regulations).
- Proven ability to liaise with Regulatory Agencies.
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Interpret and apply relevant guidelines, legislation, policies, and market practice to ensure that Takeda’s operates within acceptable boundaries, while maximizing performance and revenue.
- M&SA Operational Plan
- Food & Drug Act and regulations
- Good Clinical and Manufacturing practices
- PAAB Code of Advertising Acceptance
- Health Canada policies, guidelines, and forms; ICH guidelines
- IMC Code of Ethical Practices
- Bilingual in French and English, both written and spoken
- Negotiation skills in order to resolve conflicts and negotiate contracts with outside vendors and health authorities.
- Marketing, clinical development and international regulatory strategies in order to develop regulatory projects and ensure project compliance.
- Market competitors to increase knowledge of the market in which Takeda competes and to help Takeda retain a competitive advantage.
- Demonstrate problem-solving ability and generates alternative solutions prior to elevation of issues to Manager.
EDUCATION, LICENSES/CERTIFICATIONS, EXPERIENCE
- BS/BA University degree in Health Sciences
- Master or Advanced Degree
- Bilingual English/French preferred
- 5 years work experience in Regulatory Affairs or related field
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required
- Requires approximately 20% travel
As a result of the COVID-19 pandemic and the need to strengthen and promote health protection within Takeda, employment is conditional upon the ability to provide authorized proof of full COVID-19 vaccination status, at least 14 days prior to starting employment with Takeda. Takeda acknowledges its obligations under the applicable human rights legislation and will comply with its duty to accommodate in appropriate cases.
Time TypeFull time
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- Create an exceptional people experience
- Responsibly translate science into highly innovative, life-changing medicines and vaccines
- Protect our planet
- Unleash the power of data and digital
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