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Job Description
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, Global Regulatory Affairs Devices and Combination Products remotely.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Global Regulatory Affairs CMC Devices team, you will be empowered to lead the development and implementation of innovative combination product and device regulatory strategies for assigned development and commercial products, and a typical day will... include:
OBJECTIVES:
- Utilizes technical combination product and device knowledge, regulatory expertise and global regulatory lessons learned to drive internal consistency and influence effective change management
- Monitors global regulatory landscape to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance
- Represents Takeda on external regulatory consortia and standards committees to influence industry best practices, policy and standards
- Manages and mentors staff members
ACCOUNTABILITIES:
- Responsible for demonstrating Takeda leadership behaviors
- Provides leadership and guidance to GRA Devices and Combination Products regulatory strategists to ensure development and implementation of innovative global regulatory strategies for all products within assigned portfolio
- Provides technical, strategic and tactical regulatory guidance to product teams by defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned products
- Proactively identifies, analyses and manages complex combination product and device-related regulatory risks, ensuring timely communication with relevant stakeholders and management
- Develops / leads development of device-related dossier content for global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions, etc.)
- Acts as combination product and device regulatory expert for GRA Devices and Combination Products team
- Builds and manages relationships through active partnering with key internal and external stakeholders
- Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labeling, etc) to ensure effective strategies are developed and project execution is on target
- Relationship management and constructive partnering with global Health Authorities (e.g., FDA, EMA, PMDA, NMPA, Competent Authorities, etc.)
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 10+ years of pharmaceutical Regulatory CMC and Device experience, including experience as a Device regulatory lead for drug-device combination products; international experience strongly preferred.
- Staff management experience is required
- Experience leading cross-functional submission teams
- Proven ability to provide strategic regulatory guidance to drug-device combination product and device development, registration, and post-market support teams
- Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (i.e., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions and their amendments/supplements)
- Understanding of scientific principles and regulatory requirements relevant to global drug-device combination product development and post-market support;
- Able to identify, prioritize and resolve issues of critical importance; provide sound regulatory advice and make informed decisions on regulatory issues for which there may not be clear/specific regulatory guidance
- Demonstrate leadership, problem-solving ability, flexibility and teamwork
- Exercise good judgement in elevating and communicating actual or potential issues to line management
- Excellent written and oral communication skills required
- Active participation in external Agency/Industry groups/forums expected
PHYSICAL DEMANDS:
- Routine demands of an office based environment
- Manual dexterity required to operate office equipment (i.e., computers, phones, etc.)
- Carrying, handling and reaching for objects
- Ability to sit or stand for long periods of time while traveling
TRAVEL REQUIREMENTS:
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 10-30% travel
Location and Salary Information:
- Location(s): Remote
- Base Salary Range: $185,000.00 - $210,000.00 based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off
- If candidate is not eligible for any benefits or other comp., those can be excluded
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at
takedajobs.com
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No Phone Calls or Recruiters Please.
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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.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
