Job Description

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
• Glassdoor Reviews and Company Rating

Success Profile

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

• Detail-Oriented
• Proactive
• Problem-Solver
• Results-Driven
• Organized
• Multi-Tasker

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.

- Regulatory Affairs Associate Should able to work on Europe -post approval Administrative and CMC activities. CMC and safety variations, MAA submissions, withdrawals submissions with strong EU submission knowledge

• Experienced in CMC post approval submissions for EU and ROW Markets and Should have hands on experience liaising with various health authorities
• Strategic thinking on CMC & Safety variations.
• Exposure to tools like Document Management System (DMS/ Viva Vault) and Regulatory Information Management System (RIMs/Life Sphere) is an added advantage.
• Associate level, 2-5 years of experience