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Manager, Regulatory Affairs

Bengaluru, Karnataka, India Date posted 07/05/2024 Job ID R0000024245

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.

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
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

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.

Responsibilities

  • 10+ yrs relevant experience in Clinical Trial Regulatory Submissions.
  • Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.
  • Expertise in handling the CTIS database and submitting EU CTR is desirable.
  • Provides guidance to project team members
  • Works within broad project guidelines and facilitates issue and conflict resolutions
  • Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives
  • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
  • Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
  • Produces quality work that meets the expectations and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
  • Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives
  • Actively manages performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses, scorecards)
  • Assures PAREXEL policies and procedures are communicated to line personnel in alignment with their staff’s local country
  • Provides a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear
  • Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)

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