Regulatory Affairs Manager
3 weeks ago
Representing a leading force in the pharmaceutical industry, our client is dedicated to pioneering life-saving therapies. We are currently seeking a talented Regulatory Affairs Manager to join their team, where you'll play a pivotal role in leading regulatory efforts. This position requires a blend of technical expertise and strategic acumen to navigate approval submissions and oversee lifecycle management for groundbreaking pharmaceuticals.
MAIN RESPONSIBILITIES- Develop and implement regulatory strategies for assigned pharmaceutical products, ensuring alignment with global standards and regulations.
- Efficiently manage the lifecycle and submission pipelines, maintaining adherence to time constraints.
- Act as the primary liaison with regulatory authorities, addressing inquiries and managing communication on regulatory issues.
- Stay abreast of evolving regulatory requirements, guidelines, and trends to inform and adapt regulatory strategy.
- Collaborate with internal stakeholders to align regulatory strategies with business objectives.
- Contribute to the development of the company's long-term regulatory strategy, identifying emerging trends and proposing proactive solutions.
- Ensure compliance with ethical, legal, and regulatory standards.
- Play a key role in maintaining the regulatory database, ensuring timely updates of regulatory information.
- Develop plans for regulatory compliance and product labeling, providing guidance throughout the product introduction process.
- Keep informed about changes in regulatory requirements in relevant countries.
- Relevant Bachelor's Degree (Bachelor's Degree in Pharmacy is an added advantage).
- Minimum of 5-7 years in the pharmaceutical industry, with a focus on innovative pharmaceutical pipelines, particularly in oncology and rare diseases.
- Proven track record of regulatory successes in end-to-end new drug/generic applications.
Note: Candidates demonstrating aptitude, a strong desire to learn, and adaptability may be considered, even if they don't meet all the specified requirements.
ESSENTIAL QUALITIES- Strong analytical skills to assess complex regulatory requirements and develop effective compliance strategies.
- Excellent communication skills to collaborate with cross-functional teams and communicate regulatory updates at all organizational levels.
- Detail-oriented mindset to ensure accuracy and completeness in all regulatory documentation and submissions.
Apply with your latest CV, detailing your relevant key achievements in regulatory affairs. We look forward to a confidential discussion about your potential role in our distinguished company.
Principal Consultant: Cheong Yee Yin
Registration Number: R22108633
EA License Number: 17C8502
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