Regulatory Operations Specialist II Job at Fortrea in Mumbai with expertise in safety assessment, toxicology, and regulatory compliance. Apply online today.
Location: Mumbai
Experience: 4–6 Years
Application Mode: Online Application
Job Type: Verified Job
Fortrea, a globally recognized name in pharmaceutical research and development, has announced an excellent opportunity for experienced professionals in toxicology, safety assessment, and regulatory compliance. The organization is looking for qualified and dedicated candidates for the position of Regulatory Operations Specialist II. Regulatory Operations Specialist II Job at Fortrea
This role is designed for individuals who are passionate about regulatory operations, product safety evaluations, toxicology reviews, and non-clinical documentation. The position offers a hybrid working model, enabling you to contribute from both office and remote environments as needed. Regulatory Operations Specialist II Job at Fortrea
This detailed post provides a complete overview of the job responsibilities, qualifications, skills required, and the application process. It is designed to help candidates fully understand the role before applying. Regulatory Operations Specialist II Job at Fortrea
About Fortrea
Fortrea is a leading organization in the pharmaceutical and life sciences sector, committed to advancing global health through innovative research, regulatory excellence, and safety assessment. With a strong focus on product development, toxicology evaluation, regulatory submissions, and patient safety, Fortrea supports pharmaceutical companies in bringing high-quality and compliant products to market. Regulatory Operations Specialist II Job at Fortrea
The company’s team consists of highly skilled professionals who specialize in drug development, clinical research, regulatory affairs, toxicology, and analytical science. Fortrea emphasizes accuracy, scientific rigor, and regulatory integrity in every project. Employees benefit from a collaborative culture, global exposure, professional growth, and advanced learning opportunities. Regulatory Operations Specialist II Job at Fortrea
Job Overview – Regulatory Operations Specialist II
The Regulatory Operations Specialist II will play a vital role in supporting Fortrea’s regulatory and non-clinical documentation functions. The position involves ensuring product safety, preparing key toxicology reports, authoring regulatory documents, and ensuring compliance with health authority guidelines. Regulatory Operations Specialist II Job at Fortrea
This role is ideal for candidates with expertise in PDE/OEL calculation, impurity assessment, raw material safety evaluations, and regulatory toxicology.
Key Responsibilities
Below is an in-depth look at the responsibilities associated with this role:
1. PDE / OEL Calculation and Report Preparation
You will be responsible for calculating Permissible Daily Exposure (PDE) and Occupational Exposure Limits (OEL) for various pharmaceutical and cosmetic substances. This includes:
- Understanding toxicological endpoints
- Interpreting NOAEL, LOAEL, TTC, and other safety parameters
- Preparing scientifically sound and compliant assessment reports
These calculations help ensure safe handling and usage levels during manufacturing and product development.
2. OTC / Self-Care Formulas Safety Assessment
You will conduct safety assessments for over-the-counter (OTC) and self-care formulations. Tasks involve:
- Reviewing ingredient toxicology
- Ensuring compliance with regional and international safety standards
- Identifying potential risks in the formulation
This ensures that products are safe for consumers before market release.
3. Raw Material Safety Assessment
You will analyze raw materials used in drug and self-care product formulations. Responsibilities include:
- Reviewing toxicological data
- Identifying hazardous components
- Ensuring materials comply with regulatory and safety guidelines
4. Extractable and Leachable (E&L) Safety Assessment
You will evaluate potential extractables and leachables from packaging components or manufacturing equipment. This includes: Regulatory Operations Specialist II Job at Fortrea
- Conducting or reviewing E&L studies
- Assessing risks related to human exposure
- Preparing safety evaluation reports
E&L assessments help prevent harmful contaminants from entering the final product.
5. Impurity Qualification
Ensuring the safety of impurities present in pharmaceutical formulations is a critical part of this role. Duties include:
- Reviewing impurity profiles
- Conducting toxicology assessments
- Supporting qualification processes in line with ICH guidelines
6. INCI-Tox Profile Preparation
You will prepare International Nomenclature of Cosmetic Ingredients (INCI) toxicology profiles that support the safety evaluation of cosmetic and personal care ingredients.
7. Authorship of Non-Clinical Overview (Module 2.4)
You will author the Non-Clinical Overview section of regulatory submissions, which is an essential part of Module 2 in CTD documentation. This includes:
- Summarizing pharmacology, toxicology, and safety data
- Interpreting scientific literature
- Ensuring content aligns with global regulatory expectations
8. Toxicology Literature Review and Report Writing
A key part of the role includes conducting in-depth toxicology literature reviews. Responsibilities include: Regulatory Operations Specialist II Job at Fortrea
- Searching scientific journals, databases, and regulatory sources
- Extracting relevant toxicological data
- Preparing clear and concise reports that support regulatory submissions
This ensures that regulatory documents are evidence-based and scientifically strong.
Required Qualifications
Candidates applying for this role should meet the following requirements: Regulatory Operations Specialist II Job at Fortrea
Educational Qualifications
- M.Pharm, MSc, Toxicology, Pharmaceutical Sciences, or Regulatory Affairs
- Bachelor’s degree with strong experience may also be considered
Experience
- Minimum 4 to 6 years of experience in regulatory operations, toxicology, safety assessment, or pharmaceutical sciences
- Experience in pharmaceutical, personal care, cosmetic, or related industries is preferred
Technical Skills
- Strong understanding of toxicology principles
- Proficiency in PDE/OEL assessment
- Knowledge of E&L, impurities, and raw material safety
- Experience in preparing regulatory documents
- Good command over scientific writing
Soft Skills
- Excellent written and verbal communication skills
- Strong analytical and problem-solving abilities
- Ability to work in a hybrid environment
- Strong attention to detail
- Ability to coordinate with cross-functional teams
Why Join Fortrea?
Joining Fortrea gives you the opportunity to work with industry experts, cutting-edge tools, and global clients. Key benefits include: Regulatory Operations Specialist II Job at Fortrea
- Competitive salary and growth opportunities
- Exposure to regulatory projects across multiple markets
- Opportunities for learning and upskilling in toxicology and regulatory operations
- Strong organizational support and mentorship from senior professionals
- Hybrid working model offering flexibility
How to Apply
Candidates who meet the eligibility criteria and are interested in this role can apply online.
Steps to Apply:
- Visit the official Fortrea careers page.
- Search for the job title “Regulatory Operations Specialist II – Mumbai”.
- Click on the job listing to view full details.
- Select Apply Online to begin the application process.
- Fill out the application form with accurate details and upload your updated resume.
- Submit the form and note the application confirmation number.
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