Senior Director GRA Pharmaceuticals
2 months ago
How you will contribute:
- Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages
- Combines knowledge of scientific, regulatory and business issues to ensure the regulatory filings are of high quality and right first time.
- Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
- Globally influences and is generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry.
- Responsible for demonstrating Takeda leadership behaviors. Serve as a member of the GRA-CMC Pharmaceuticals Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.
- Provides leadership of GRA CMC Pharmaceuticals – in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.
- In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.
- Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and external stakeholders (Health authorities, Industry counterparts/associations, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.
- Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.
- Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities.
- Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
- Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
- Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally.
- Leads or plays a key role on the relevant internal Takeda governance committees.
Minimum Requirements/Qualifications:
- Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
- Minimum of 15 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
- Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
- Actively engaged in major industry associations (e.g. CPC, EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH).
- Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
- Languages: Fluent in English, additional languages desirable
- High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams.
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