Ass. Director, Regulatory Lead, EUCAN

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Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Come join our team as Ass. Director, EUCAN Regulatory Lead, Gastrointestinal & inflammation.

OBJECTIVE

• Define, develop, lead regional strategies
• to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
• to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives within the therapeutic area of responsibility.
• Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
• Manages interactions with EMA and national authorities in the Europe Region for products within their responsibility.

Accountabilities

• Partners with Takeda Global and Regional counterparts to define, author and lead the regional regulatory strategy considering regulatory, scientific, medical and market access guidelines and perspective.
• Monitors and identifies regulatory requirements and trends to provide regulatory guidance and expertise to global development team and/or higher internal governance bodies.
• Develops and maintains effective working relationships with internal Regulatory, Cross-functional Teams, consultants and/or business partners
• Lead strategy execution for on-time achievement of regional submissions and approvals.
• Acts as deputy to the regional therapeutic area lead and/ or regional regulatory head, attending internal leadership team meetings, when required.
• Collaborates with global colleagues to resolve regional critical challenges impacting global regulatory strategies if applicable.
• Proactively builds/strengthens external stakeholders relationship (Regulatory Agencies, external experts, industry organizations, etc) to achieve Takeda strategic goals.
• Leads and coordinate preparation meetings and/or interactions with regulatory Agencies meetings negotiates on behalf of project team as necessary and represents Takeda in these meetings/interaction accordingly.
• May be required to lead and provide regional regulatory input in due diligence for licensing opportunities, development and/or marketed products.
• Identifies regulatory risk and proposes mitigations accordingly.
• Mentors team members, if required.

Education, Behavioural Competencies And Skills

• BSc degree is a must, advanced degree(s) preferred
• Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
• Solid working knowledge of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing, in the EU, with a good understanding of basic regulatory requirements in emerging markets. Understanding of evidence requirements beyond the regulators (e.g. HTA bodies).
• Understanding and ability to interpret complex scientific issues across projects and therapeutic area of responsibility as it relates to regulatory requirements and strategy.
• Preferred experience in managing multiple filings; or managing multiple programs in late development area in the EU region with global involvement
• Generally strong in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Able to train/develop junior colleagues in regulatory strategy.

PHYSICAL DEMANDS

• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)
• Carrying, handling and reaching for objects
• Ability to sit or stand for long periods of time while traveling.

Travel Requirements

• Willingness to travel to various meetings, including overnight trips.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time