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 robust background in regulatory affairs, with expertise in CMCc and RM.
Roles and Responsibility
Develop and implement regulatory strategies for recent 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.
Solid 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.