POSITION SUMMARY
As the Senior/RA Executive, you will bring your technical and strategic expertise to the forefront, managing the lifecycle and submission pipelines in a time-efficient manner. You will ensure that processes align with global standards and regulatory frameworks, while working closely with internal and external stakeholders to develop effective regulatory strategies.
NOTE: This position may be filled at Senior Regulatory Affairs Executive or Regulatory Affairs Executive and will be determined based on the candidate's experience and qualifications.
KEY RESPONSIBILITIES
- Develop and implement regulatory strategies for the company's products in the assigned region, in line with global standards and regulations.
- Manage the preparation and submission of regulatory applications to health authorities, including new drug applications.
- Serve as the primary contact with regulatory authorities, including communicating with them on regulatory issues and addressing inquiries and requests for information
- Maintain up-to-date knowledge of regulatory requirements, guidelines, and trends to inform regulatory strategy development.
- Work closely with internal stakeholders, such as R&D, Clinical Operations, and Marketing, to align regulatory strategies with business objectives.
- Contribute to the development of the company's long-term regulatory strategy, including identifying emerging regulatory trends and proposing proactive solutions.
- Ensure compliance with ethical, legal, and regulatory standards.
- Collaborate in the maintenance of the regulatory database, ensuring timely updates of regulatory information.
- Develop plans for regulatory compliance and product labeling to ensure consistency and provide guidance throughout the process of introducing products to the market.
- Keep up-to-date with changes in regulatory requirements in relevant countries by monitoring relevant regulatory changes.
REQUIREMENTS
- Relevant Bachelor's Degree (Bachelor's Degree in Pharmacy is an added advantage)
- 3 - 5 years in the pharmaceutical industry with experience working with innovative pharmaceutical pipelines especially in the space of oncology and rare diseases.
ESSENTIAL QUALITIES
- Strong analytical skills to assess complex regulatory requirements and develop effective strategies to ensure compliance.
- Excellent communication skills to collaborate with cross-functional teams and communicate regulatory strategies and updates to stakeholders at all levels of the organization.
- Detail-oriented mindset to ensure accuracy and completeness in all regulatory documentation and submissions.
If you're seeking an enriching opportunity to elevate your career in regulatory affairs with a distinguished company, I greatly encourage you to apply with your latest CV and we shall get in touch shortly for a confidential discussion.
The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
