Associate Manager Regulatory Affairs

ASTO Life Sciences is seeking an Associate Manager Regulatory Affairs to join our team. This role is ideal for a professional with a strong background in regulatory compliance, specifically within medical devices, in vitro diagnostics, and healthcare products. The Associate Manager will be responsible for preparing, reviewing, and submitting comprehensive regulatory dossiers and technical documentation in compliance with DRAP regulations and Medical Devices Rules, 2017, including all relevant amendments. The candidate must have a solid understanding of the regulatory landscape and ensure that all submissions meet the highest standards of accuracy and completeness. The position requires someone with a Pharm-D, M.Phil, MSc, BS in Pharmacy, Life Sciences, Biotechnology, Microbiology, or related disciplines and at least 3 to 5 years of relevant regulatory affairs experience. This person will not manage a team but will collaborate closely with cross-functional teams to achieve regulatory goals and ensure product compliance throughout their lifecycle. The Associate Manager will play a critical role in maintaining up-to-date legal documents and assuring regulatory compliance for all products handled by ASTO Life Sciences. The role involves constant interaction with regulatory bodies and requires a proactive approach to understanding changes in regulations and their implementation. This position offers the opportunity to work in a dynamic environment where attention to detail, analytical skills, and a thorough understanding of regulatory frameworks are essential. The successful candidate will contribute significantly to the company's product development and market introduction processes, ensuring timely approvals and adherence to regulatory obligations.
Responsibilities

Prepare, review, and submit regulatory dossiers and technical documentation to DRAP and other regulatory agencies according to established guidelines.
Ensure compliance with DRAP regulations and Medical Devices Rules, 2017, including keeping abreast of updates and amendments that impact product registrations and regulatory submissions.
Maintain and update legal and regulatory documents to reflect current regulatory requirements and company standards.
Conduct thorough regulatory assessments and gap analyses to support product development and lifecycle management.
Collaborate with cross-functional teams including quality assurance, R&D, manufacturing, and marketing to ensure regulatory requirements are integrated throughout the product development process.
Support regulatory audits and inspections by preparing documentation and responding to regulatory queries or deficiencies.
Monitor changes in the regulatory environment and provide timely guidance to the company to ensure ongoing compliance with local and international regulations.
Assist in the development and implementation of internal regulatory policies and procedures to improve compliance efficiency.
Provide training and knowledge sharing sessions to internal teams on regulatory requirements and best practices.
Act as a liaison with regulatory authorities to facilitate efficient communication and resolution of regulatory issues.