Regulatory Affairs Associate - CMC

We are looking for a highly skilled and experienced Regulatory Affairs Associate to join our team at Ruputed Pharmaceutical Company in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs, particularly in CMC.

Roles and Responsibility

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

Job Requirements

• Bachelor's degree in Pharmacy or a related field.
• Proven experience in regulatory affairs, preferably in CMC.
• Strong knowledge of pharmaceutical regulations and guidelines.
• Excellent communication and project management skills.
• Ability to work effectively in a fast-paced environment and meet deadlines.
• Strong analytical and problem-solving skills.