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
Key Accountabilities:
Submission Coordination:
- Assist in the preparation and coordination of regulatory submissions, including:
- Investigational New Drug (IND) applications
- Investigational Medicinal Product Dossiers (IMPDs)
- Post-approval commitments
- Annual reports
- Responses to regulatory authority questions
- Ensure all submissions are complete, accurate, and compliant with regulatory requirements
- Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation
Regulatory Assessment Support:
- Support the team in conducting regulatory assessments of manufacturing changes
- Analyze the potential impact of manufacturing changes on regulatory compliance
- Assist in preparing documentation to support manufacturing change assessments
Regulatory Compliance:
- Stay current with relevant regulations and guidelines
- Contribute to the development and maintenance of standard operating procedures (SOPs) related to regulatory submissions
- Ensure adherence to regulatory requirements throughout the submission process
Cross-functional Collaboration:
- Work closely with various departments, including R&D, Clinical, Manufacturing, and Quality Assurance
- Facilitate effective communication between internal teams and regulatory authorities
- Participate in project team meetings to provide regulatory input and updates
Documentation Management:
- Maintain accurate and up-to-date regulatory documentation
- Assist in the organization and archiving of regulatory submissions and correspondence
- Contribute to the development and maintenance of regulatory databases
Desired Qualities:
- Proactive and self-motivated with a strong work ethic
- Ability to work effectively in a team environment
- Analytical mindset with strong problem-solving skills
- Adaptable to changing priorities and regulatory landscapes
- Commitment to continuous learning and professional development
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