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Job Description

Job Title: Regulatory Affairs Manager

Location: Singapore

About the role:

The job requires the person to manage Regulatory Affairs for all Company products to ensure they are in compliance with statutory and company requirements and maximize the contribution of Regulatory Affairs to the achievement of business objectives through active assistance in the development and implementation of the company’s policy positions and product advocacy strategies.

How you will contribute:

• RA registered pharmacist for Singapore LOC

• Plan, strategize and monitor regulatory filings for timely submissions and approvals of new product registrations and variation applications.

• Life cycle management of existing product portfolio while ensuring smooth supply of products

• Manage labeling changes, safety updates, artwork development and artwork approval of packaging material components.

• Build effective working relations with the regulatory agency and follow-up closed on approval of products registration and variations

• Work with all appropriate local functions to develop and implement the best regulatory strategies/plans to support commercial goals and product launch excellence.

• Develop annual regulatory budget for Singapore filings/variations/registrations/license renewals.

• Review promotional material in relation to product campaign launches and ongoing product marketing activities.

• Support regulatory review or artwork/promo material/ad-hoc requests for partners’ products

• Update and maintain local and global-associated databases with Malaysia & Singapore regulatory information.

• Keep tracking of policy changes, current and emerging issues, understand their potential impact on business and build corresponding strategies to support business

• Develop and maintain good and effective relations with local authorities and pharmaceutical associations

• Participate in local authority inspections and internal audits when applicable to the regulatory affairs function.

• Assist Head of Regulatory Affairs, MYSG on regulatory assignments as and when required.

Specific Competencies

• Highly organized and self-disciplined

• High level of integrity and good morals.

• Innovative and resourceful with excellent analytical and problem-solving skills

• Excellent communication and facilitation skills

• A good team player with excellent interpersonal skills

• Excellent written and oral communication skills in English

What you bring to Takeda:

• Registered pharmacist in Singapore

• Minimum Bachelor's degree in Pharmacy

• A minimum of 3 years of relevant Regulatory Affairs expertise in the pharmaceutical industry

• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes

• Knowledge of national legislation and regulations relating to medicinal products

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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