Parexel Hiring for Regulatory affairs associate at Remote Full Time

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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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 MA. Knowledge of change evaluation according to country guidelines Experience in managing lifecycle activities in the EU markets.
• Knowledge of CTD guidelines

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

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