ChatGPT said:
Senior Regulatory Affairs Manager
Location: Manila, Metro Manila
Job Type: Full Time
Job Level: Senior
Travel: Minimal (if any)
Job Description:
Takeda, with over 240 years of experience in translating science into breakthrough medicines, is seeking a Senior Regulatory Affairs Manager to oversee regulatory activities for all company products. This role will ensure compliance with statutory and company requirements, contributing to the achievement of business objectives by shaping policy positions and product advocacy strategies.
Key Responsibilities:
Regulatory Filings: Plan, strategize, and monitor regulatory filings for timely submissions and approvals of new product registrations and variation applications.
Lifecycle Management: Manage life cycle maintenance of existing products, ensuring a smooth supply chain.
Labeling and Safety Updates: Oversee labeling changes, safety updates, artwork development, and approval of packaging material components.
Leadership: Lead regulatory activities in the Philippines, ensuring the implementation of effective regulatory strategies.
Communication: Collaborate with business partners and regulatory/health bodies.
Team Development: Lead and develop the regulatory team to support business growth.
Policy Influence: Work with Public Affairs to shape public policies and address regulatory challenges for in-line and pipeline products.
Regulatory Engagement: Develop and maintain effective relationships with the Philippines FDA and other pharmaceutical associations.
Qualifications:
Education: Bachelor's degree in Pharmacy; Pharmacy professional license.
Experience: At least 10 years of relevant Regulatory Affairs experience in the pharmaceutical industry.
Preferred: Experience in registering and launching vaccines.
Skills: Strong communication, project management, and problem-solving abilities. Deep knowledge of local regulations for pharmaceuticals, biotech, vaccines, and medical devices.
What Takeda Offers:
Career Growth: Opportunity to grow within a global leader in specialty pharmaceuticals.
Inclusive Culture: An environment that fosters innovation and excellence.
Benefits: Takeda offers comprehensive employee benefits and a supportive work environment.
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