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Job DescriptionAbout the role:The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Regulatory Lead is accountable for recommending and implementing regulatory strategy and coordinating life cycle activities across the portfolio of PDT products.
How you will contribute:- Serves as the global regulatory lead for one or more projects and and includes leadership of the Global Regulatory Team (GRT) composed of core regulatory support functions.
- Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of plasma derived therapies, while ensuring compliance with applicable regulatory requirements.
- Serves as the primary liaison to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities in Japan, the European Union and EEA region, Canada and emerging markets.
- Accountable for the creation and execution of global regulatory strategies for assigned programs and ensures the global regulatory strategies for assigned programs are up-to-date.
- Collaborates with EU & Canada, Japan, China and/or other regional counterparts in compiling global regulatory strategies and works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.
- Leads the global regulatory sub team (GRT) and represents the GRT at GPT, cross-functional sub teams and working groups.
- Creates high quality, complaint regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives.
- Accountable for all US FDA submissions and approvals for assigned programs. Works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.
- Leads and manages FDA health authority interactions/meetings related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions.
- Ensures GRT, GPT, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with the assigned team and management; understands probabilities of technical success for the solutions. Brings any critical regulatory topics for assigned programs to the regulatory review forum for discussion.
- Ensures accurate, up-to-date reporting of program status and milestones globally through the InterACT system and regulatory dashboard and leverages the Dragonfly visualization tool to highlight any major discrepancies for assigned programs.
- May lead regulatory review in due diligence for licensing opportunities.
- Strong knowledge of global regulatory requirements for drugs and biologics.
- Ability to function as the lead interface with the US FDA and support regional and local regulatory affairs teams with health authority interactions
- Demonstrated ability to develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities
- Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve commercial goals
- Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU, and international markets and versed in the overarching regulatory policy landscape in which biopharmaceutical companies operate
- Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
Minimum Requirements/Qualifications:- BSc degree preferred and advanced degree a plus. BA accepted
- Minimum of 8 years of pharmaceutical industry experience, with a minimum of 5 years of within a regulatory strategy role
- Plasma or biologics experience preferred
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions
- Strong knowledge of global regulatory requirements and prior FDA interactions/submissions experience
- Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
- Must work well with others and within global teams
- Demonstrated leadership skills and ability to inspire colleagues and influence in a matrixed environment
More about us: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.
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Takeda Compensation and Benefits SummaryWe 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.
For Location:Boston, MA
U.S. Base Salary Range:149,100.00 - 234,300.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO StatementTakeda 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.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job ExemptYes
