15 Aug
|
Naukri Healthcare Jobs
|
Delhi
15 Aug
Naukri Healthcare Jobs
Delhi
We are looking for a highly skilled and experienced qualified to join our team as a Drug Regulatory Affairs specialist in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a solid background in regulatory affairs and a passion for ensuring compliance with regulatory requirements.
Roles and Responsibility
Develop and implement regulatory strategies to ensure compliance with pharmaceutical regulations.
Prepare, review, and submit regulatory documents such as clinical trial applications, marketing authorizations, and periodic safety update reports.
Collaborate with cross-functional teams including R&D;, Quality Assurance, and Manufacturing to ensure alignment with regulatory requirements.
Monitor and analyze changes in regulatory environments that could impact product development or commercialization.
Provide training and guidance to internal stakeholders on regulatory requirements and procedures.
Maintain accurate records of regulatory interactions, submissions, and correspondence.
Job Requirements
Bachelor's degree in Pharmacy (B.Pharm) or Master's degree in Science (M.Sc.).
Minimum 2 years of experience in drug regulatory affairs or a related field.
Strong knowledge of pharmaceutical regulations including FDA, EMA, and ICH guidelines.
Excellent communication, writing, and project management skills.
Ability to work independently and collaboratively as part of a team.
Robust analytical and problem-solving skills with attention to detail.
📌 Drug Regulatory Affairs Professional Delhi
🏢 Naukri Healthcare Jobs
📍 Delhi