The purpose of the Sr. Director, Global Regulatory CMC is to combine knowledge of scientific, regulatory and business issues to ensure Takeda s products are manufactured or distributed to meet required legislation. Incumbent will develop and lead the development and implementation of CMC regulatory strategies for Takeda products throughout the development and commercial lifecycle. This individual has global influence and is generally considered a key opinion leader and resource within Takeda as well as externally. This individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory CMC strategy
- Develops global Regulatory CMC strategies and updates based on regulatory and business changes. Acts as CMC regulatory expert for global project teams/task forces and is accountable for recommending global CMC regulatory strategy.
- Provides leadership of global GRA CMC business units consisting of geographically dispersed RA CMC professionals, including staff management and development.
- Relationship management and constructive partnering with international Health Authorities (such as FDA, EMA, etc.)
- Builds and manages relationships through active partnering with key internal and external stakeholders including Alliance Partners such as AbbVie, Pfizer, etc., as well as across platform functions within Takeda, such as Pharmaceutical Development, Pharmaceutical Sciences, Commercial Manufacturing & Supply Chain, Global License Management, and Quality Assurance.
- Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interations with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for CMC.
- Represents as required the regulatory function in the evaluation of new product opportunities internally and externally
- Leads or plays a key role on internal Takeda governance committees
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- A minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degrees preferred.
- Must have a minimum of 15 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry, international experience strongly preferred. (e.g. Pharmaceutical Development, Pharmaceutical Sciences, Analytical Development, Production, Quality Assurance)
- Significant staff management experience is required. Experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with international regulatory authorities is also required.
- Demonstrate a solid working knowledge of drug development process and knowledge of ICH RA CMC regulatory requirements; EU, Canada, and ROW experience highly desirable.
- Candidates must be able demonstrate strong relationship management, project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).
- Active pharmaceutical industry/Agency engagement is strongly desired and encouraged.
- Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
- Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral dosage forms) is required.
- Demonstrated track record for successful interactions with FDA and preferably other global health authorities related to CMC submissions.
- Demonstrated ability to work well within a matrix structure in a complex environment.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 30 % travel.
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