Are you looking to advance your career in regulatory operations within the pharmaceutical industry? Fortrea is currently seeking a dedicated Regulatory Operations Specialist II to join our dynamic team in Mumbai. This opportunity allows you to work in a hybrid environment, providing a perfect blend of remote work and in-office collaboration.
About Fortrea
Fortrea is a leader in the pharmaceutical sector, committed to delivering innovative solutions that enhance patient care and safety. With a focus on research and development, we strive to improve the quality of life for patients around the globe. Our team is comprised of talented professionals dedicated to upholding the highest standards in regulatory compliance and safety assessment.
Job Description
As a Regulatory Operations Specialist II, you will play a key role in our product safety and regulatory compliance initiatives. Your responsibilities will include:
- PDE / OEL Calculation and Report Preparation: Analyze and compute permissible daily exposure (PDE) and occupational exposure limits (OEL) for various substances.
- OTC / Self-Care Formulas Safety Assessment: Conduct thorough safety assessments for over-the-counter (OTC) and self-care products to ensure their compliance with regulatory standards.
- Raw Material Safety Assessment: Evaluate the safety of raw materials used in formulations to mitigate risks.
- Extractable and Leachable Safety Assessment: Perform assessments on the extractable and leachable properties of materials to ensure product safety.
- Impurity Qualification: Assess and validate impurities present in formulations to meet regulatory guidelines.
- INCI-Tox Profile Preparation: Develop comprehensive INCI-Tox profiles for OTC and self-care ingredients.
- Authorship of Non-Clinical Overview (Module 2.4): Prepare and author the non-clinical overview as required for regulatory submissions.
- Toxicology Literature Review and Report Preparation: Conduct extensive literature reviews in toxicology and prepare reports to support regulatory activities.
Qualifications
- Bachelor’s or Master’s degree in a relevant field such as Toxicology, Pharmaceutical Sciences, or Regulatory Affairs.
- Proven experience in regulatory operations, particularly in the pharmaceutical or cosmetic sectors.
- Strong analytical and written communication skills.
