EUCAN Regulatory Therapeutic Area Team Lead – Oncology
vor 2 Wochen
We are seeking a highly experienced Regulatory Affairs professional to lead our Oncology Therapeutic Area team in Europe and Canada. As the EUCAN Regulatory Therapeutic Area Team Lead, you will be responsible for overseeing and directing all regulatory activities related to oncology products.
Key Responsibilities- Provide strategic leadership and oversight to a team of regulatory strategists who define, develop, and lead Europe & Canada (EUCAN) regulatory strategies to maximize regulatory success.
- Ensure recruitment, line management, and development of direct reports; provide direction, support, mentoring, and strategic guidance to fulfill scope of project work.
- Provide strategic and tactical advice and guidance and regional regulatory expertise to regional and global leadership teams on how to achieve timely and efficient conduct of all development and/or life-cycle management programs pertaining to oncology.
- Ensure team resourcing and appointment of appropriately skilled EUCAN Regulatory Leads to Global Regulatory Teams and Submission Working Groups.
- Manage or support and oversee health authorities interactions in the region and key external stakeholder management.
- Demonstrate Takeda leadership behaviors and encourage the team to live up to the Takeda Code of Conduct and leadership behaviors.
- Develop capabilities of staff members.
- Ensure the planning and management of all regulatory activities throughout the product life cycle, for the Therapeutic Area portfolio in close partnership with Global Regulatory TA Leadership, Regional cross-functional teams, and LOC management.
- May act as deputy to the Regional therapeutic area lead and/or Regional regulatory head, attending internal leadership team meetings, as appropriate.
- Presents regional regulatory strategies to leadership/senior management.
- Ensures that staff members stay current with regulations/guidance in the region for impact on drug development plans, registration, and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain regulatory compliance.
- Provides regulatory expertise to senior management on drug development, registration, and/or post-marketing compliance and life cycle management.
- Evaluates new business development opportunities and/or participates on due diligence teams.
- In coordination with local regulatory leads and Global Regulatory Policy & Innovation, provides strategic advice on emerging trends and regulations.
- Oversees and ensures fulfillment of post-marketing commitments.
- Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy.
- Supports Access to Medicines initiatives to develop and implement innovative patient access strategies.
- Drives the development of effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company's consultants and Business Partners as required.
- Proactively builds/strengthens external stakeholders (Regulatory Agency, external experts, industry organizations, etc.) to achieve Takeda strategic goals and objectives.
- Oversees and is accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule.
- Understands the importance and oversees regulatory dossiers for value and access strategies and encourages the design of an integrated regulatory submission & access strategy in partnership with access functions as needed across the business portfolio.
- Interacts directly or oversees with HA (EUCAN), as required. Represents Takeda in Health Authority meetings that may have critical impact on overall strategy or Takeda reputation; may negotiate on behalf of project team, as necessary.
- Ensures coverage for projects within the therapeutic area, identifies possible gaps, and proposes solutions to the management.
- Works closely with cross-functional teams to ensure regional regulatory considerations are integrated into global development plans.
- Identifies regulatory risks and develops mitigation strategies to support successful product approvals and lifecycle management.
- Drives innovation in regulatory process improvements, including the use of advanced technologies and methodologies to enhance submission quality and efficiency.
- Leads and provides regional regulatory input in due diligence for licensing opportunities, development, and/or marketed products.
- BSc. Advanced scientific related degree preferred.
- A minimum of 15 years of regulatory affairs experience in the pharmaceutical/biotechnology industry within the EU region.
- Comprehensive knowledge of regional regulatory requirements and guidelines for oncology products.
- Proven track record of successful regulatory submissions and approvals for oncology products.
- Experience with advanced therapeutic medical products (Cell & gene therapy) will be advantageous.
- Solid regulatory experience, including knowledge of regulations and guidance applicable in the region governing drugs and biologics in all phases of development; preferred is a good understanding of regulatory requirements in other regions globally (US, EU, Emerging markets). Experience leading interaction with Health Authorities.
- Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively.
- Must be able to provide guidance in interpreting regulatory regulations and guidelines. Must be able to formulate Regional regulatory strategy to achieve competitive and accelerated product approvals.
- Strategic thinker with exceptional problem-solving and decision-making capabilities, yet is flexible to adapt to changing priorities and deadlines in a dynamic environment.
- Provides oversight of regulatory strategy for development and lifecycle management products in oncology in EUCAN region. Experience with managing EU initial MA or indication/extension application procedures or global involvement is required. Experience in managing multiple filings; or multiple programs including global involvement.
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Zürich, Zürich, Schweiz Takeda VollzeitJob Title: EUCAN Regulatory Therapeutic Area Team Lead – OncologyAbout the Role:We are seeking a highly experienced and skilled Regulatory Therapeutic Area Team Lead to join our EUCAN team. As a key member of our regulatory affairs team, you will be responsible for overseeing and directing all regulatory activities related to oncology products in Europe...
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Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryWe are seeking a highly skilled and experienced Regulatory Therapeutic Area Team Lead to join our EUCAN Oncology team. As a key member of our regulatory affairs team, you will be responsible for providing strategic leadership and oversight to a team of regulatory strategists, ensuring the successful development and approval of oncology products in...
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Zürich, Zürich, Schweiz Takeda VollzeitJob DescriptionOverviewTakeda is seeking a highly skilled Regulatory Therapeutic Area Team Lead to oversee and direct all regulatory activities related to oncology products in the EUCAN region.Key ResponsibilitiesProvide strategic leadership and oversight to a team of regulatory strategists who define, develop, and lead Europe & Canada (EUCAN) regulatory...
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Zürich, Zürich, Schweiz Takeda VollzeitJob DescriptionOverviewTakeda is seeking a highly skilled Regulatory Therapeutic Area Team Lead to join our EUCAN team. As a key member of our regulatory affairs team, you will be responsible for overseeing and directing all regulatory activities related to oncology products in the EUCAN region.Key ResponsibilitiesProvide strategic leadership and oversight...
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Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryWe are seeking a highly skilled and experienced Regulatory Therapeutic Area Team Lead to join our EUCAN team. As a key member of our regulatory affairs team, you will be responsible for overseeing and directing all regulatory activities related to oncology products.Key ResponsibilitiesProvide strategic leadership and oversight to a team of...
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Zürich, Zürich, Schweiz Takeda VollzeitAbout the RoleWe are seeking a highly experienced and skilled Regulatory Therapeutic Area Team Lead to join our EUCAN team. As a key member of our regulatory affairs team, you will be responsible for providing strategic leadership and oversight to a team of regulatory strategists, ensuring the successful development and approval of oncology products in the...
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Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Lead to join our EUCAN Oncology team. As a key member of our team, you will be responsible for overseeing and directing all regulatory activities related to oncology products in the EUCAN region.Key ResponsibilitiesProvide strategic leadership and oversight to a team of regulatory...
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Zürich, Zürich, Schweiz Takeda VollzeitJob SummaryWe are seeking a highly skilled Regulatory Affairs Lead to oversee and direct all regulatory activities related to oncology products in the EUCAN region.Key ResponsibilitiesProvide strategic leadership and oversight to a team of regulatory strategists who define, develop, and lead Europe & Canada (EUCAN) regulatory strategies to maximize...
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