Fortrea Opens Regulatory Operations Role for Pharma Freshers

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Fortrea Hiring Regulatory Operations Assistant I for Pharma Graduates

Global clinical research organization Fortrea has announced hiring for the position of Regulatory Operations Assistant I in Mumbai, creating a valuable opportunity for B.Pharm and life science graduates who want to enter the regulatory affairs and drug development sector.

For many pharmacy graduates, breaking into global regulatory operations can be challenging. This Fortrea opening provides early‑career professionals the chance to work on regulatory documentation submitted to major global health authorities including the US FDA, European Medicines Agency, Japan PMDA, and other international regulatory agencies.

With pharmaceutical companies expanding global drug approvals and clinical development programs, professionals trained in regulatory operations and compliance are becoming essential to the healthcare industry.

Company Overview

Fortrea is a global contract research organization (CRO) focused on clinical development, regulatory services, and drug lifecycle support for pharmaceutical and biotechnology companies. The company provides scientific expertise across clinical trials, regulatory strategy, pharmacovigilance, and data management.

Operating in multiple countries, Fortrea supports pharmaceutical sponsors in bringing innovative therapies to market while ensuring compliance with international regulatory guidelines. The organization works closely with global health authorities and industry partners to accelerate drug development and maintain high standards of quality and patient safety.

Fortrea is known for its strong regulatory science capabilities and its ability to help pharmaceutical companies prepare documentation, submissions, and compliance reports required for drug approvals in regulated markets.

Career Outlook for Safety Science & Regulatory Analysts in 2026

The pharmaceutical regulatory landscape is evolving rapidly as companies expand global clinical trials and introduce new therapies across regulated markets. By 2026, demand for professionals specializing in regulatory operations, pharmacovigilance, and safety science analytics is expected to increase significantly.

Regulatory operations analysts play a critical role in compiling drug development documentation, managing regulatory submissions, and ensuring compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and International Council for Harmonisation (ICH) guidelines.

Professionals who start their careers in regulatory operations often progress into roles such as Regulatory Affairs Specialist, Global Submission Manager, Drug Safety Associate, or Regulatory Strategy Lead. Experience with electronic regulatory submission systems and global regulatory frameworks can open doors across pharmaceutical companies, CROs, and biotechnology firms.

Job Role & Responsibilities

The Regulatory Operations Assistant I will support preparation, compilation, and management of regulatory documentation required for global drug submissions.

Key responsibilities include:

• Create, review, and compile regulatory specifications and documentation for submission to international health authorities
• Support regulatory submissions to agencies such as the US FDA, European Medicines Agency (EMA), Japan PMDA, and other global authorities
• Ensure compliance with Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and current Good Manufacturing Practices (cGMP)
• Perform analytical testing including assay, related substances, dissolution, and content uniformity
• Support validation activities such as cleaning validation and process validation
• Maintain regulatory and training documentation according to company and client requirements
• Operate laboratory and analytical instruments including HPLC, UPLC, GC, Karl Fischer, dissolution testers, particle size analyzers, and analytical balances
• Assist in onboarding, training, and mentoring new associates within regulatory operations teams
• Perform tasks assigned by department leadership and support regulatory project requirements

The role requires attention to detail, documentation accuracy, and strong collaboration with quality assurance, analytical science, and regulatory teams.

Eligibility / Qualifications

Candidates interested in this regulatory operations opportunity should meet the following qualifications:

• Bachelor’s degree in Pharmacy or related life science discipline
• Advanced degrees such as M.Pharm, MSc, or PhD may also be considered
• Knowledge of pharmaceutical product lifecycle and regulatory compliance standards
• Familiarity with GxP, ICH guidelines, and regulatory submission processes is desirable
• Strong analytical and documentation skills
• Ability to manage multiple tasks and maintain regulatory accuracy

Relevant education backgrounds include: B.Pharm, M.Pharm, MSc Pharmaceutical Chemistry, MSc Biotechnology, MSc Microbiology, MSc Biochemistry, Pharmaceutics, Pharmaceutical Analysis, Regulatory Affairs.

Experience

Fortrea is seeking candidates with early career experience in pharmaceutical regulatory or quality environments.

• 0 to 3 years of experience in regulatory affairs, quality assurance, analytical science, pharmaceutics, or drug development
• Knowledge of regulatory documentation systems or electronic regulatory information management systems is an advantage
• Technical proficiency in Microsoft Office and documentation tools

Candidates with certifications or diplomas in regulatory affairs may receive additional consideration.

Location & Salary

Location: Mumbai, India

Salary: Competitive compensation based on experience and role responsibilities. Global CRO organizations typically provide structured salary packages, performance incentives, and long‑term career development opportunities.

Application Process

Interested candidates can apply through the official Fortrea careers portal using the link below.

Apply here:
https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Mumbai/Regulatory-Operations-Assistant-I_26654

Applicants should prepare an updated resume highlighting regulatory knowledge, analytical laboratory skills, and familiarity with pharmaceutical compliance guidelines.

Due to application deadlines, candidates are encouraged to apply as soon as possible.

Frequently Asked Questions

Who can apply for the Fortrea Regulatory Operations Assistant role?
Pharmacy graduates and life science candidates with knowledge of pharmaceutical regulatory processes can apply.

Is this role suitable for freshers?
Yes. Candidates with 0–3 years of experience in regulatory affairs, quality assurance, or pharmaceutical analytical roles are eligible.

What skills are important for regulatory operations careers?
Knowledge of pharmaceutical regulations, documentation accuracy, analytical testing methods, and regulatory submission processes are important skills.

What career growth opportunities exist in regulatory operations?
Professionals can progress into Regulatory Affairs Specialist, Global Regulatory Manager, Drug Safety Associate, or Regulatory Strategy roles within pharmaceutical companies and CRO organizations.

Summary

Category	Details
Company	Fortrea
Vacancies	Regulatory Operations Assistant I
Required Education	B.Pharm, M.Pharm, MSc Pharmaceutical Chemistry, MSc Biotechnology, MSc Microbiology, MSc Biochemistry
Experience	0–3 years in regulatory affairs, QA, analytical science or pharmaceutics
Location	Mumbai
Department	Regulatory Operations

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