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Regulatory Affairs Manager
3 weeks ago
**PURPOSE**
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.
**Education, Experience & Skills**:
**Occupational Knowledge**
- BS/BA University degree in Health Sciences; Master or Advanced Degree
- 5 years work experience in Regulatory Affairs or related field
- 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.
- 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
**Business Knowledge**
- 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.
**TRAVEL REQUIREMENTS**
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required
- Requires approximately 10% 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.
**Locations**:
Toronto, Canada
**
