As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

• >7 years of experience in reviewing and approving Raw Materials and formulations
• Understanding, analyzing, and interpreting requirements from diverse regulatory environments throughout the product development life-cycle
• Knowledge of global regulations on REACH, DEG/EG, Nitrosamine, Elemental impurity, Halal, RSS, Allergens
• Good Knowledge of OECD, ICHQ3D
• Check and implement regulatory compliance of EU, US, ASEAN, China, Arab countries.
• Review and approval of raw materials and their constituent information to ensure completeness and accuracy and evaluate potential impact to current guideline and restrictions and/or reporting/documentation requirements as per the client shared guidelines.
• Evaluation of formulations for Innovation platforms, new product development and marketed products to ensure compliance as per requirement.
   
• Creation of Ingredient Lists according to the appropriate regulatory classification.
   
• Prepare impact assessment on the proposed changes to formulation and required remedial strategy.
   
• Support new ingredient listing submission documents.
   
• Review the changes outlined in change control form for the raw Materials used in Cosmetic & Non-NDA drugs marketed globally, complete the assessment part of the for and circulate for approval.
   
• Review of Fibers and non-woven for Compliance as per client internal guidelines.
   
• Preparation of technical justification of stability testing for the packaging material change as per the regulations.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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