Drug Regulatory Affairs

As a Drug Regulatory Affairs Specialist at MEDYUR PHARMACEUTICALS LIMITED, you will be responsible for ensuring compliance with regulatory requirements for our products. Your role will involve collaborating with cross-functional teams to drive successful product launches and maintain regulatory compliance. Your responsibilities will include preparing and submitting regulatory documentation, staying updated on global regulatory requirements, developing relationships with regulatory bodies, reviewing changes in regulatory policies, conducting regulatory impact assessments, maintaining regulatory files, and supporting regulatory inspections and audits. You will also collaborate with internal teams to develop regulatory strategies aligned with business goals and act as the primary point of contact for regulatory agency inquiries. Required qualifications for this role include a Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field, along with 2-8 years of experience in regulatory affairs within the healthcare or pharmaceutical industry. You should have in-depth knowledge of regulatory requirements and guidelines, strong analytical skills, and the ability to interpret complex regulatory documents and data. Preferred qualifications include a Master's degree in a relevant field and experience with medicines and formulations products. Technical skills required for this role include proficiency in regulatory submission software, electronic document management systems, understanding of risk management principles, and familiarity with project management tools. Soft skills and cultural fit are also important, including exceptional verbal and written communication skills, strong organizational skills, attention to detail, proactive approach, ability to work independently and collaboratively, adaptability, and resilience in a fast-paced regulatory landscape. This is a full-time, permanent position with benefits such as cell phone and internet reimbursement, day shift schedule, and performance bonus. The work location is in Faridabad, Haryana, and proficiency in English is preferred. You should have at least 2 years of experience in drug regulatory affairs.,