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
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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
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.
We are looking forRegulatory Affairs Professionalson various levels (Senior and Principal Consultant) for client dedicated projects within Parexel FSP Group who are CMC Technical Regulatory Writers. Technical Regulatory Writer is involved in the client’s regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions.
Job Responsibilities:
- Write CMC parts and new files
- Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion
- Ensure the coordination with the departments involved in the writing/review process
- Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities
- Monitor that supportive data provided by other departments are compliant
- Report significant issues
- Manage the projects within all tracking tools
- Assess the change controls that relate to pure facilities and equipment matters or work with other teams for change controls impacting both CMC and facilities.
Skills and Experience required for the role:
- Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
- Knowledge of regulatory procedures / systems / guidances
- Knowledge of biologic process and process equipment.
- Knowledge of Qualification / Validation principles.
- Manages own time to meet agreed short-term targets
- Analytical skills, creative and critical mind; ensures the coherence between contributions / quality of final results
- Good level of spoken and written English (other European language would be a plus)
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