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
Regulatory Affairs Associate & Sr. Regulatory Affairs Associate
JOB DESCRIPTION
- Handling Life Cycle Maintenance for approved products including but not limited to filing of CMC variations (for small molecule &/or biological finished formulations), Administrative Variations, Renewals, Marketing Authorization Transfers, Manufacturing Site Transfers, Site Name Change variations and Safety &/or labeling changes in varied markets including but not limied to Euprope, ASEAN and Other Regulated markets
- Review of dossiers for EU in eCTD format and International markets.
- Handling Health Authority Queries within predefined time with adequacy and accuracy, Change Control management
- Independently communicate and coordinate with various stakeholders (internal & external) to ensure timely submission of regulatory applications
- Identify gaps in existing business (regulatory) processes and trainings to perform the required tasks and input process improvements to achieve process excellence.
ELIGIBILITY CRITERIA
- Candidates with 3 to 8 years of experience in handling submissions in varied markets. Experience in handling EU submissions would be preferred.
- Candidates with experience/ in-depth knowledge in handling post approval changes EU markets
- Candidates with working experience in handling RIMS tools. Hands on experience in Veeva Vault tool would be preferred
#LI-REMOTE
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