Descrição da Vaga
* Taking into account global developmental goals, provides and communicate optimal regulatory strategic guidance on all developmental and marketed vaccines based on a strong knowledge of regulatory affairs for vaccines.
* Execute and participate in setting all regional regulatory strategy and regulatory activities for the entire vaccine portfolio, including Health Authority meetings.
* Oversees and accountable for ensuring that regulatory submissions and approvals in the region are delivered as outlined in the global regulatory strategy.
* Cross-functional collaboration with regional VBU functions and interactions with LOC counterparts/key stakeholders.
* Interact with regional trade organizations and industry group to identify regulatory trends and policy that could affect VBU.
* Interaction with CRO, as required, for clinical trials conducted in the region (VBU RAV LATAM representative).
* Responsible for regulatory oversight in Takeda electronic Trial Master File system, for the trials conducted in the region, ensuring compliance and inspection readiness
Clinical Trial related
* Regional LATAM representative in trial specific CROs meetings (SET meetings), if required
* Responsible for implementing and conducting regulatory specific electronic Trial Master File (eTMF) oversight process for the vaccine trials conducted in LATAM countries, ensuring system is inspection ready.
* RAV regional eTMF representative in case of regulatory audits involving LATAM countries.
* Addresses audit findings related to regulatory oversight activities, responsible for tracking and completion of the corrective and preventive actions, liaising with the relevant functions as required.
* Accountable for developing regional regulatory strategy for all vaccine candidates and vaccine products in region, and working with the Global Project Team RAV Lead for global regulatory development of Takeda vaccine products.
* Accountable for the vaccines related regulatory interactions and for the vaccines regulatory submissions in the region, supporting RA LOCs associates as required, ensuring that regulatory plan deliverables are met.
* Oversees the development of ongoing and proactive relationships with vaccine regulatory authorities and participates in all vaccine related regulatory meetings/interactions with Health Authorities.
* Act as the regional regulatory representative for specific development projects or marketed vaccines, as assigned. The ability to function as the regional regulatory expert is one of the key distinguishing factors for this position.
* Identifies regulatory requirements and trends in vaccines and provides regulatory guidance, and expertise to global development team and/or others
* Prepare periodic reports, strategy documents and presentations detailing Regional vaccine development and licensure activities.
* As assigned, responsible for "due diligence" and feasibility assessments.
- BS degree or equivalent in a scientific discipline; advanced preferred
- A minimum of 10 years of pharmaceutical industry experience, vaccine-specific preferred in specific-region.
- Minimum 5 years of direct regulatory affairs experience (vaccines experience required)
- Excellent regulatory judgment across multiple filings
- Prove success licensing pharmaceutical products in the region.
- Understands and interprets complex scientific issues across projects as they relate to vaccine regulatory requirements and strategy.
- Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Strong proven collaborative skills in working with multicultural teams and teams representing diverse disciplines.
- Must be strong overall, hands on approach and able to proactively identify regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Takes stand on important issues in productive, respectful way.
- Fluency in English and Spanish