We are seeking a detail-oriented Regulatory Affairs Specialist to join our team in Maharashtra. The ideal candidate will have a strong background in regulatory affairs, particularly in the areas of USDMF, ASMF, and customer DMF submissions. This role is crucial for ensuring that our products meet all regulatory requirements and are compliant with industry standards.

Key Responsibilities:
- Prepare and submit regulatory documents for USDMF, ASMF, and other relevant submissions to ensure compliance with regulatory agencies.
- Collaborate with cross-functional teams to gather necessary data and documentation for regulatory submissions.
- Monitor and interpret regulatory changes and assess their impact on the organization.
- Maintain up-to-date knowledge of regulatory requirements and industry trends.
- Provide guidance and support to internal teams regarding regulatory issues and compliance.




- Assist in the development and implementation of regulatory strategies to facilitate product approvals.

Required Skills:
- Strong understanding of regulatory affairs, particularly in the pharmaceutical or biotechnology sectors.
- Familiarity with USDMF, ASMF, and customer DMF processes.
- Excellent communication and interpersonal skills to effectively collaborate with various stakeholders.
- Strong analytical skills and attention to detail.
- Ability to work independently and manage multiple projects simultaneously.

If you are passionate about regulatory affairs and are looking to make a significant impact in a dynamic environment, we encourage you to apply for this exciting prospect.

📌 Regulatory Affairs Specialist (Mumbai)
🏢 Orbitouch Outsourcing Private
📍 Mumbai