- 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.
- 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.
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Regulatory Affairs Manager - Singapore - INTEGRITY PARTNERS PTE. LTD.
Description
Roles & ResponsibilitiesRepresenting 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
QUALIFICATIONS
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
HOW TO APPLY
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: R
EA License Number: 17C8502
Tell employers what skills you haveExcellent Communication Skills
Pharmaceutical Industry
FDA
Regulatory Compliance
Analytical Skills
Pipelines
Regulatory Affairs
Oncology
ISO
Regulatory Strategy
Adaptability
Compliance
Medical Devices
Regulatory Requirements
Life Sciences
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