Associate RA Manager

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Job Description

Job Title:  Associate Regulatory Affairs Manager

Location:  Taiwan, Taipei

About the role: 

• To handle regulatory initiatives with Health Authority for assigned projects.
• To propose appropriate regulatory strategies for optimizing product profiles and product life-cycle management.
• To ensure all regulatory actions in compliance with local regulations and internal SOP.
• To be a reliable business partner and fully support brand team to achieve company defined targets.

How you will contribute: 

• To be responsible for assigned product registration, line extension, variation, post-approval commitments, license maintenance etc. New manufacturing site plant master file (PMF) registration and maintenance in line with requirements of local regulation.
• To ensure project execution aligned with global instructions and in compliance with local regulations and company SOP.
• Provide regulatory supports as business partner to brand team to ensure achieving company defined targets.
• To keep up-to-date knowledge, personal competency in regulatory affairs fields and regularly share regulatory intelligence with APAC and global regulatory teams for synchronizing company resources to achieve company regulatory affairs goals.
• To be company representative in pharmaceutical associations to provide company regulatory inputs and to engage Health Authority on regulation harmonization/ revision and new policy decisions. To be a good partner/contributor in Health Authority key projects when feasible.

What you bring to Takeda: 

• Bachelor Degree in Pharmacy or Life Sciences (e.g. Chemistry, biology).  Pharmacist is a plus.
• Experience in pharmaceutical product registration.
• At least 6 years of pharmaceutical industry experience. Multinational company working experience is a plus.
• Excellent verbal and written communication skills in Mandarin.  Proficiency in written and oral English.
• Experience in Health Authority interactions. Ability to act as company spokesperson with Health Authorities.
• Collaborative, result-driven with a high degree of agility to adapt changing regulatory 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.

Empowering our people to shine:

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.

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