Ass. Director, Regulatory Lead, Eucan

vor 8 Monaten

Zurich, Schweiz Takeda Vollzeit

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

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