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- Relevant 2 or years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.

• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:

o Submission delivery strategy o Review of documents o Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

• Liaise closely with cross-functional members with aligned product responsibilities.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Authoring the dossier sections based on the changes to approved MAA
• Knowledge of change evaluation according to country guidelines
• Knowledge of CTD guidelines

Education:

• Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences