Description
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 100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
- Own and manage regulatory projects accounts and work towards achieving excellence in service delivery and exceeding Service Level Agreements through team of delivery manager and project managers.
- Lead the team of cross functional regulatory affairs specialist to support global specification management, raw material qualifications, change control, toxicology, analytical methods and stability reports, packaging material, labelling etc. for global product portfolio including cosmetics/consumers, pharmaceutical, medical devices and biologics.




- Set up matrix team of regulatory affairs professionals to manage the post approval life cycle maintenance. Lead and manage the regulatory affairs functions; manage delivery of regulatory affairs projects for global customers across all geographies including US, EU, APAC, MENA, LATAM, CIS etc.
- Participate in and/or lead business development activities e.g., RFI and RFP responses, lead bid defense efforts for potential current regulatory affairs project opportunities.
- Provide guidance/direction for regulatory affairs staff on development and training needs. Responsible for ensuring that staff are available for projects requiring regulatory submissions services.
- Responsible for defining RA strategies to meet submission timelines for post approval life cycle maintenance, for implementing these strategies and for the ongoing assessment of the appropriateness for continuing established regulatory strategies and for adjusting the strategies as appropriate.

📌 Director - Regulatory Affairs Operations (Pune)
🏢 Fortrea Development India Private
📍 Pune