Job Title Regulatory Affairs Executive Location Hyderabad Industry Clinical Research Organization CRO Employment Type Full time On-site Salary 17 000 - 22 000 per month Working Hours Day Shift 9 30 AM - 6 30 PM may include rotational shifts Qualification Doctor of Pharmacy Pharm D - Mandatory Experience Freshers or up to 2 years in clinical research or healthcare industry preferred Age Limit 21 - 30 years Agreement Must agree to a 2-year employment agreement Shift Flexibility Must be willing to work in rotational shifts Preferred Candidates Male Female candidates preferred Immediate Joiners Preferred Benefits Structured learning and growth opportunities in clinical research Exposure to real-time clinical trials and cross-functional collaboration Friendly professional and collaborative work environment Role Overview Prepare compile review and submit regulatory documents for clinical trials e g IND CTA NDA ANDA USA - FDA EMA ANVISA amendments renewals Manage submissions to health authorities and ethics committees IRBs in accordance with national and international regulations Act as the primary regulatory point of contact for sponsors investigators and regulatory agencies Ensure compliance with applicable regulations and guidelines e g ICH-GCP FDA EMA MHRA local authorities Track regulatory submission timelines and maintain regulatory databases Review clinical protocols informed consent forms and investigator brochures for regulatory compliance Monitor regulatory amendments and assess their impact on ongoing and future studies Support audits and inspections by regulatory authorities and sponsors Provide regulatory guidance to internal teams throughout the clinical trial lifecycle Key Responsibilities Assist in IRB IEC regulatory submissions Review protocols ICFs IBs Maintain regulatory files Track approvals timelines Coordinate with clinical PV teams Required Skills Competencies Understanding of clinical trial processes documentation and protocols Clinical trial knowledge ICH-GCP basics Excellent organizational and problem-solving skills Strong written and verbal communication skills Ability to work independently and collaboratively in a team Proficiency in MS Office and basic data management tools Attention to detail and adherence to timelines and protocols Professionalism discipline and willingness to work in rotational shifts Important Notes Mandatory Conditions Salary range is fixed - 17 000 to 22 000 maximum Working hours may extend by up to 1 hour based on business requirements Must be willing to work in rotational shifts if implemented in the futureo Should be willing to relocate to Hyderabado Commitment for 2 years is mandatory Job Types Full-time Permanent Pay 204 000 00 - 264 000 00 per year Benefits Health insurance Provident Fund Work Location In person