Senior Technical Regulatory Advisor – Pharmaceuticals (Senior/Executive Director)

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Job Description

Senior Technical Regulatory Advisor – Pharmaceuticals (Senior/Executive Director) 

OBJECTIVES/PURPOSE

• To define and implement an external engagement strategy, governance and associated capabilities in line with the patient centric values of Takeda to ensure that Takeda is recognized by regulatory authorities and industry peers as a thought leader in the areas of innovation, science/technology, Regulatory sciences   

• Engaging a network of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global Quality to monitor and influence the evolving technical regulatory /quality CMC environment and execute internal change to continuously improve our products, systems and submissions 

• Collaborating with Regulatory policy and Intelligence team as well as the global quality policy intelligence team to develop internal processes and communication mechanisms to assess emerging regulatory expectations for their impact on the company, and to achieve the overall vision and objectives 

• Engage with GRA CMC & Device Leadership in the talent development processes to provide mentoring of Top Talent and Subject Matter Experts to enhance external technical advocacy/influencing capability. 

ACCOUNTABILITIES

• Accountable for mentoring and coaching team members to enable proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner.  

• Collaborate closely with Technical SME’s across Takeda to craft company positions to influence HA’s and thereby enable Technical innovation and incorporation of digital innovation into Takeda development and commercial framework. Engage with regulators and industry associations to represent the company on strategic topics. 

• Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, Pharm SCi GMS, GQ etc.) and external stakeholders (Industry representatives, PHRMA, Health authorities etc). Relationship management and constructive partnering with Health Authorities and relevant local organizations to drive Takeda positions and influence scientific approach and thought process to technical topics.  

• Ensure that a network of subject matter experts exists and mentors / supports the internal key opinion leaders in their external engagement activities. 

• Ensure early identification and assessment of emerging technical RA topics/expectations, prioritize and gain senior leader alignment to define the company´s strategy and involvement. 

• Influences changing regulations and guidance; interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend CMC Module 3/Module 2 submissions with intent to streamline and increase efficiency through use of automation and digital tools. 

• Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people. 

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Bachelor’s or Advanced Degree in Life Sciences, Pharmacy, Chemistry, Biology or related discipline. 

• Languages: Fluent in English (oral and written); additional languages desirable     

• Minimum of 15-20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Quality/Regulatory/Technical area . A candidate with strong experience in small molecules is highly preferred. 

• The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events. 

• He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role 

• Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, WHO). 

• Actively engaged in major industry associations (e.g. EFPIA, PhRMA, 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. 

• Must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data 

• High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams. 

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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