Job Description

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