Parexel Regulatory Affairs Associate Job Openings Bangalore
Regulatory Affairs Associate Job Opportunities for Bachelors / Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences Candidates at Bangalore Location
About the Parexel :
- Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world.
- Parexel provides the most comprehensive drug development capabilities of any CRO worldwide.
- Parexel is global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.
Experience; Relevant 2+ years of experience in Regulatory Affairs-CMC should be willing to work in EU Shifts (12:00 – 9.00 PM)
- Understand the regulatory framework for EU/US and RoW
- Liaise closely with cross-functional team members.
- Experience of handling RIM tools – Veeva Vault specifically.
- Knowledge of CTD guidelines – M1 and M3.
- Excellent communication skills.
Education:
Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life
Relevant experience in regulatory package preparation, compilation, and submission to Health Authorities in various markets with a focus on EU countries.
- Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissions
- Knowledge of EU country regulations
- Able to contribute as a local SME for countries and collaborate with global teams and other stakeholders for increasingly more complex regulatory submissions for Clinical Trial Applications.
- Experience in handling health authority queries
- Good understanding and knowledge of ICH guidelines and Ethics Committee requirements for Clinical Trial Applications in EU countries.
- Clear oral and written communication skills
- Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well
- Execute and maintain submission delivery plans, and submission content plans, and proactively provide status updates to designated stakeholders.
- Strong communications skills and ability to guide and mentor team members.
- Ability to work in different time zones
- Ability to work independently
Education: Bachelors / Masters in Pharmacy OR Bachelors/ Masters in any of the Life Sciences
