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
- Level: Mid
- 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.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Are you passionate about regulatory affairs in the life science industry? Do you thrive in a dynamic team environment and enjoy managing complex projects? Parexel is seeking a talented Regulatory Affairs Associate to join our growing team!
As a Regulatory Affairs Associate at Parexel, you will be at the forefront of managing and coordinating regulatory submissions across various markets. This role offers an excellent opportunity to develop your expertise in regulatory affairs while working with a diverse range of clients and stakeholders.
Role Responsibilities:
- Manage lifecycle maintenance activities, including renewals, variations, and responses to deficiency letters
- Coordinate submission and management work in Veeva Vault
- Collaborate with various stakeholders, attending regular calls and meetings
- May serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
- Ensure project team delivers high-quality work meeting client expectations and timelines
- Manage project financials and identify new business opportunities
- Deliver consulting services within your area of expertise
- Maintain professional interactions with clients and internal teams
Skills and experience required for the role:
- University degree in a life science discipline
- Initial years of regulatory experience in EU and other non-EU markets preferred
- Proficiency in Module 1 and 3 writing preferred
- Strong organizational and prioritization skills
- Excellent communication and teamwork abilities
- Ability to work independently and under guidance of Project Leads or Technical SMEs
- Commitment to continuous learning and self-development
- Fluent in English, written and spoken. French language skills would be a plus.
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