Senior Director and Head, CMC Regulatory Affairs Technical Advocacy (London, Zurich or Boston based) - Now Hiring

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Takeda is currently looking for a Senior Director and Head, CMC Regulatory Affairs Technical Advocacy - The role can be located in the UK, in Zurich or Boston. To summarize, the main activities of this role are the following :

• 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 intellilgence 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

• Assess the landscape of major industry associations and joint regulator/industry initiatives to identify and optimize external technical regulatory advocacy/engagement strategies, including company representation  and goals, at both the executive level for policy setting and strategy, and the subject matter expert level for technical advocacy

• Design and implement governance processes and cross-divisional/cross-functional governance bodies that support the nomination and participation of internal thought leaders in Industry Associations and joint Regulator/Industry initiatives.
• 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.
• 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.
• Globally influences and is generally considered a key opinion leader and resource within Takeda and externally. 
• 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.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Extensive knowledge and experience of Bio-pharmaceutical Research, Development and Manufacturing.
• Comprehensive understanding of the pharmaceutical industry with experience in regulatory filings across the lifecycle, understanding of the global regulatory landscape  and external technical regulatory/quality/manufacturing environment
• Expert knowledge of biopharmaceutical CMC development, product registration and maintenance regulations with experience in championing innovation in technical areas.
• Experience in operating in a multi-disciplinary drug development environment, including working within and managing across multiple regions/countries/cultures
• Knowledge and understanding of relevant emerging regulations and related processes
• Knowledge of diverse therapeutic areas and recent innovative treatments

Leadership

• Drives towards vision of being recognized by Regulatory Authorities as a thought leader in the Industry in the areas of innovation, science and technology, quality and regulatory compliance, and continuous improvement.
• Strategic role to prepare the internal organization for emerging regulatory expectations in GxP areas, across the lifecycle of biopharmaceutical products at Takeda.
• High visibility of the incumbent representing the company in major industry initiatives and in interactions with regulators, as well as internal visibility with executive leadership.
• Possess outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative.
• Ensures that every team member knows what is expected of their role and what it takes to be successful.  Helps employees grow through challenging assignments so they may realize their full potential.
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company
• Ability to distil complex issues and ideas down to simple comprehensible terms
• Executive leadership presence and confidence

Decision-making and Autonomy

• Ability to collaborate with and achieve results through others; builds strong and sustainable relationships and interact within all levels of the organization
• A member of Global CMC & devices Leadership team and an extended/ad-hoc member of the Global Regulatory Affairs Policy and Intelligence team
• Ad-hoc participation in senioe leadership teams as needed
• Responsible for internal processes and systems to support external representation are implemented and effectively working.

Interaction

• Benchmarking results and emerging expectations from external activities are communicated effectively across internal divisions/functions and used to drive action and continuously improve internal products, submissions and quality and scientific processes and systems.
• Through the incumbent’s engagement with regulators and industry peers, the reputation of the company is continuously enhanced. The company is involved in strategic initiative with regulators and considered a “go to” organization for benchmarking by peer companies and regulators.
• An internal robust pipeline of talent development and external engagement succession planning process is in place to ensure continuous representation in major Industry Associations/Regulatory forums on the strategy and policy setting level as well as for technical topics.

Innovation

• A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make Takeda a model for the industry
• This function serves to “bring the outside into Takeda” as well as influence external regulators and peers regarding innovative treatments.

Complexity

• An external technical regulatory engagement strategy is defined and implemented across complex and diverse regulatory frameworks worldwide to ensure that the company is adequately represented across major Industry Associations/Regulatory forums at both the strategy/policy setting level as well as for technical topics, to achieve the overall vision to be recognized as a thought leader in the external environment.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
• Languages: Fluent in English (oral and written); additional languages desirable   
• Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Quality/Regulatory.
• 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.
• High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams.

#LI-Remote