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
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Education: Bachelors / Masters in Pharmacy OR Bachelors/ Masters in any of the Life Sciences