We are seeking a detail-oriented Pharmaceutical Regulatory Affairs Specialist to join our team in Maharashtra. The ideal candidate will have a strong understanding of regulatory requirements and processes related to drug master files (DMFs) and active pharmaceutical ingredients (APIs). This role is crucial in ensuring that our products meet all necessary regulatory standards and are compliant with industry guidelines.

Key Responsibilities:
- Prepare and submit regulatory documents, including USDMF and ASMF submissions, ensuring accuracy and compliance with regulatory standards.
- Collaborate with cross-functional teams to gather necessary information for regulatory submissions and address any queries from regulatory authorities.
- Maintain up-to-date knowledge of regulatory changes and industry trends that may impact our products and submissions.




- Act as a point of contact for regulatory inquiries and provide guidance on regulatory requirements to internal teams.
- Support the development and implementation of regulatory strategies for new products and changes to existing products.

Required Skills:
- Strong knowledge of USDMF, ASMF, CEP, and customer DMF processes.
- Familiarity with API regulations and compliance requirements.
- Excellent communication and interpersonal skills to effectively collaborate with various stakeholders.
- Detail-oriented with strong organizational skills to manage multiple projects and deadlines.
- Ability to work independently and as part of a team in a fast-paced workplace.

If you are passionate about regulatory affairs and want to contribute to the success of our pharmaceutical products, we encourage you to apply for this exciting opportunity.

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