Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals

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At Takeda, we are a forward-looking, world-class R&D organization that 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 possible in order to bring life-changing therapies to patients worldwide.

• Leads the chemical/synthetic molecule CMC regulatory team in the development and implementation of global CMC regulatory strategies for products throughout the development and commercial lifecycle.

• Combines the knowledge of scientific, regulatory, and business issues to ensure the registration and life cycle maintenance (CMC regulatory aspects) of products 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.

• Influences changing regulations and guidance documents; interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy.

• Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives.

• Responsible for demonstrating Takeda leadership behaviors. Serve as a member of the GRA-CMC Leadership team, giving input to the key strategic, portfolio, human capital, and financial decisions.

• Provides leadership of GRA CMC Pharmaceuticals regulatory team and in conjunction with direct reports, manages resources, establishes a vision, and collaborates with stakeholders in global Reg CMC and across the enterprise to deliver against them.

• In conjunction with members of the team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams and stakeholders in a timely manner.

• 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's position and influence the 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 organizations 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

• Advanced Degree or Ph.D. 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 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. 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.

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

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation Community Outreach Programs and a company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $193,200- $276,000, based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.