Ass. Director, Regulatory Lead, Eucan
vor 4 Wochen
**Job Type**:
Full Time**Job Level**:
Senior**Travel**:
Minimal (if any)
Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.
At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.
**Job ID** R0109028**Date posted** 10/30/2023**Location** Zurich, Canton of ZurichAt Takeda, we are a forward-looking, world-class R&Dorganizationthat 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 possiblein order tobring life-changing therapies to patients worldwide.
Join our exceptional team and discover a world of possibilities at Takeda We are seeking a talented Ass. Director, Regulatory Lead, EUCAN to join our Zurich based RA development team for an exciting early phase product within R&D.
**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
- A minimum of 8 years of 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.
- Strong working experience of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing in the EU and working with centralized procedures, with a good understanding of basic regulatory requirements in emerging markets. Understanding of evidence requirements beyond the regulators (e.g. HTA bodies).
- Solid experience in developing and leading regional regulatory strategies
- 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 t
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