Vanja Petric

Regulatory Affairs Specialist @Phortas

Aachen, DE

Provide regulatory guidance and support to cross-functional internal and client teams, including R&D,(non)clinical, CMC, safety- Ensure compliance with regulatory requirements, including but not limited to FDA, EMA, and other international regulations- Prepare and submit regulatory documents for various regulatory procedures, including pre-approval procedures (e.g. Orphan Drug Designations, Pediatric Plans, Scientific Advice, INDs, clinical trial applications, etc.), marketing authorization procedures (NDAs, BLAs, EU MAAs, and other regions), post-approval procedures (variations, renewals, etc.) and other regulatory filings- Interact with regulatory agencies on behalf of clients- Interact with clients, leading and organising meetings- Prepare presentations for management, clients and other stakeholders- Perform research on various regulatory affairs and other relevant topics- Prepare and distribute reports- Maintain overviews, trackers and other organizational and project management tools- Keep up-to-date with changes in regulatory requirements and industry trends- Develop and maintain relationships with key stakeholders, including regulatory agencies, consultants, and industry associations- Set up, adjust and continuously optimize regulatory processes (SOPs, Work Instructions and company processes) and interfaces (internal and external); supervise vendors in regulatory affairs on behalf of Phortas- Contribute to continuous improvement initiatives within the regulatory affairs function- Lead and manage other delegated regulatory affairs activities for the company- Involved in business development part of the company

University of Belgrade - Faculty of Pharmacy

Master's degree

Valjevska gimnazija, Valjevo-Serbia

High School Diploma