Regulatory Operations Job at Fortrea | Freshers Pharmacy | Apply Now
The clock is ticking for one of the most significant entry-level openings in the 2026 pharmaceutical sector. With only 10 hours left to apply, the Regulatory Operations Job at Fortrea in Pune represents a high-velocity opportunity for those looking to jumpstart a career in drug development. If you are a new graduate searching for Freshers Pharmacy Jobs, this position offers a rare chance to bridge the gap between pharmaceutical theory and the complex global submission standards required by health authorities like the FDA, EMA, and PMDA.
- Job Position: Regulatory Operations Assistant I
- Location: Pune
- Job Requisition ID: 261275
About the Company
Fortrea stands as a premier, global contract research organization (CRO) dedicated to providing full-service clinical development and patient access solutions. Operating as an independent powerhouse, the organization partners with emerging biotechs and large-scale pharmaceutical giants to navigate the intricate path from lab to life-changing therapy. A Fortrea Career is characterized by a commitment to scientific excellence and a culture that values precision, quality, and high customer service.
Regulatory Operations Job Key Responsibilities
In this Regulatory Operations Job, you will be responsible for the technical backbone of pharmaceutical submissions. You are not just handling paperwork; you are ensuring that product quality (CMC) data is compiled, reviewed, and approved to meet the strict standards of global health authorities.
- Submission Compilation: Prepare and review Chemistry, Manufacturing, and Controls (CMC) documentation to support new product registrations and post-approval lifecycle maintenance.
- Specification Management: Create and revise raw material and packaging specifications to ensure every component of a drug product meets safety and quality standards.
- Change Control Oversight: Coordinate with cross-functional teams to perform impact assessments of change controls and manage documentation for Out of Specification (OOS) or Out of Trend (OOT) results.
- Stability & Evaluation: Support the evaluation of stability data and dissolution profiles, ensuring the drug product remains effective throughout its shelf life.
- Stakeholder Coordination: Manage import license requirements and record management, acting as a liaison between internal departments and external clients.
Regulatory Operations Job Candidate Profile: Ideal for Freshers Pharmacy Jobs
Fortrea is looking for precise, goal-oriented individuals who are ready to take ownership of their professional development. This is one of the top Freshers Pharmacy Jobs available in Pune for 2026.
- Educational Foundation: Bachelor’s in Pharmacy (B.Pharm) or a related science degree. Candidates with an Advanced Degree (Master’s or PhD) are also highly encouraged to apply.
- Experience Level: 0–1 years of experience in Regulatory Affairs, Quality Assurance, or Analytical Science.
- Technical Proficiency: Strong command of the Microsoft Office suite and a willingness to learn electronic data management systems (e.g., Regulatory Information Management or RIM).
- Guidelines Knowledge: A basic understanding of GxP, ICH-GCP, and the pharmaceutical product life cycle is desirable.
- Soft Skills: Excellent organizational skills, meticulous attention to detail, and the ability to work in a fast-paced environment with competing priorities.
In summary, the Regulatory Operations Job at Fortrea is a definitive milestone for any aspiring pharmaceutical professional. By securing a Fortrea Career in 2026, you gain an unshakeable foundation in the regulatory guidelines required for international product registration. Among the competitive landscape of Freshers Pharmacy Jobs, this role stands out for its global reach and its focus on high-quality, efficient processes. If you are a proactive problem-solver with a passion for quality and scientific accuracy, your journey to becoming a leader in regulatory operations starts here—but you must act fast before the April 18 deadline closes.
