Are you an experienced professional in pharmaceutical regulatory operations looking for a rewarding career in Mumbai? Fortrea, a leading global contract research organization (CRO), is hiring a Regulatory Operations Expert to join their dynamic team. This full-time role offers an exciting opportunity to contribute to cutting-edge drug development projects, ensuring compliance with global regulatory standards. If you have expertise in in vitro dissolution testing, analytical science, and regulatory guidelines, this is your chance to make an impact in the pharmaceutical industry.
Job Responsibilities
As a Regulatory Operations Expert, you will play a pivotal role in driving analytical and dissolution projects while ensuring high-quality outcomes and regulatory compliance. Key responsibilities include:
- Providing analytical support for developmental and comparative dissolution projects from client sites.
- Acting as an interface with contract laboratories, suppliers, customers, and peers to enhance project performance.
- Coordinating with CROs to ensure timely project completion.
- Designing and monitoring scientific experiments, recommending adjustments based on results.
- Preparing test methods, technical documents, protocols, and reports.
- Ensuring accurate data recording, retention, summarization, and interpretation.
- Analyzing dissolution data sets and troubleshooting instrument or method issues.
- Adhering to Good Manufacturing Practices (GMP) and safety requirements.
- Collaborating with Drug Product Development, Regulatory CMC, and Specification Management teams.
Qualifications and Skills
To excel in this role, candidates must meet the following minimum qualifications:
- Education: Master’s in Pharmacy or related science degree (or equivalent); PhD preferred. Fortrea may consider equivalent experience in lieu of educational requirements.
- Experience: 10-12 years in the analytical field or 7-9 years in analytical science, formulation science, or material management within drug development and manufacturing.
- Skills:
- Expertise in in vitro dissolution testing, including multimedia and comparative dissolution.
- Knowledge of FDA-SUPAC, ICH guidelines, and regulations for emerging markets (e.g., China, Latin America).
- Strong verbal, written, and presentation skills.
- Leadership and multitasking abilities with attention to detail.
- Ability to influence stakeholders and coach team members.
- Experience with audits and regulatory compliance.
- Familiarity with medical terminology, GxPs, and adverse event reporting.
Preferred Qualifications:
- Diploma or certification in Regulatory Affairs.
- Experience in Design of Experiments (DoE) and statistical evaluation.
- Knowledge of data management systems, pharmaceutical product lifecycle, or Management Information Systems (MIS).
Benefits of Joining Fortrea
- Career Growth: Work on global drug development projects with opportunities to collaborate with international teams.
- Impactful Work: Contribute to innovative pharmaceutical solutions that improve patient outcomes.
- Professional Development: Enhance your skills in regulatory affairs, dissolution testing, and analytical science.
- Supportive Environment: Join a collaborative, office-based team in Mumbai with a focus on excellence.
