Regulatory Affairs - CSCC & RM

We are looking for a highly skilled and experienced professional to join our team as Regulatory Affairs - CSCC & RM in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs, with expertise in CMCc and RM.

Roles and Responsibility

• Develop and implement regulatory strategies for new products and submissions.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
• Prepare and review regulatory documents, including clinical trial applications and marketing authorizations.
• Conduct thorough reviews of regulatory submissions to identify potential issues or deficiencies.
• Provide guidance and support to internal stakeholders on regulatory matters.
• Stay up-to-date with changing regulatory requirements and guidelines.

Job Requirements

• Strong knowledge of CMCc and RM regulations and guidelines.
• Excellent analytical and problem-solving skills, with attention to detail.
• Ability to work effectively in a fast-paced environment and meet deadlines.
• Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
• Experience working in the Pharmaceutical & Life Sciences industry is preferred.
• Any graduate degree from a recognized institution.