Regulatory Affairs (RA) Specialist

at  PHARMENG TECHNOLOGY PTE LTD

REGULATORY STRATEGY

• Prepares submission dossiers for post-approval variations within agreed timelines.
• Maintains general knowledge of latest regulatory requirements.
• Establish and maintain good working relationship with internal and external stakeholders.
• Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter.
• Determine regulatory relevance and perform variation assessments.

KEY REQUIREMENTS

• Degree/Polytechnic Diploma, preferably in the Sciences (Pharmacy, Life Sciences, Biological Sciences etc)
• 1 year of experience in regulatory affairs or related work experience.
• Good knowledge and understanding of pharmaceutical & scientific processes.
• Good understanding of the regulatory environment, guidelines and processes for product registration.
• Attention to detail
• Ability to work with data and basic regulatory SOPs (learning agility and ability to learn independently/on the role will be a big plus)
• Takes ownership of tasks and strong ability to collaborate with team members

To contribute as an integral member to Singapore RA team to support all regulatory activities. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory approval across various therapeutic areas, in alignment with core business objectives.