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
Submission Planning and Management:
- Plan, manage, and track regulatory submissions in collaboration with the Regulatory Lead
- Prepare high-quality global submissions, either in-house or via CRO
- Ensure timely delivery of compliant submissions to global health authorities
- Develop and maintain submission timelines, identifying and managing critical path activities
Regulatory Operations Expertise:
- Provide regulatory operations expertise to cross-functional submission project teams
- Promote and implement best practices for excellence in planning, preparation, and delivery of regulatory submissions
- Stay current with evolving regulatory requirements and submission standards
Project Team Leadership:
- Act as the primary point of contact for project and/or submission teams for major submissions
- Coordinate and lead submission-related meetings and activities
- Facilitate effective communication between internal teams, CROs, and other external partners involved in submission preparation
Quality Assurance:
- Ensure submissions meet all regulatory requirements and internal quality standards
- Implement and maintain quality control processes for submission documents
- Conduct quality checks on submission components and compiled dossiers
Submission Process Improvement:
- Identify opportunities for process improvement in submission preparation and management
- Contribute to the development and implementation of standard operating procedures (SOPs) related to regulatory submissions
- Participate in initiatives to enhance submission tools and technologies
Cross-functional Collaboration:
- Work closely with various departments, including Regulatory Affairs, Clinical Development, and Medical Writing
- Liaise with CROs and other external partners involved in submission preparation
- Provide guidance and training to team members on submission requirements and processes
Desired Qualities:
- Proactive and self-motivated with a strong work ethic
- Ability to work effectively in a team environment and lead cross-functional groups
- Excellent problem-solving skills and the ability to adapt to changing priorities
- Strong interpersonal skills with the ability to build relationships across various stakeholder groups
- Commitment to continuous learning and staying current with regulatory trends and technologies
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