Parexel Hiring for Junior Regulatory Affairs Associate at Bangalore Full Time

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

• Full Time
• Travel: Yes
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Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

Rewards

• Global Impact

  We are one truly global team working together to propel each client´s journey ahead faster.

• Balance

  We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

• Collaboration

  Work with industry leaders and subject matter experts.

• Freedom

  The ability to innovate, ask “what if” and try new solutions without fear of failure.

• Variety

  Opportunities to work on multiple accounts – never boring!

• Management

  Strong management with depth of experience working for global health authorities.

• 0-2 Years experience in CTA preparation and Compilation. Experienced with preparation/review of Clinical Trial Authorization Packages for India
• Awareness of regulatory requirements
• Review and evaluate technical and scientific data and reports required for submission
• Monitor applicable regulatory requirements; assure compliance with the company’s and external standards Coordinate with global team for documentation
• Responding to queries raised by regulatory authorities
• Maintain regulatory files in a format consistent with requirements
• Label reviews
• Tracking submissions
• CTRI registration

Qualifications

Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline