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
- Glassdoor Reviews and Company Rating
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.
Responsibilities
If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you!
Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department.
Key Responsibilities:
Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions.
Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements.
Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed.
Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards.
Health Authority Engagement: Support the preparation of materials for health authority engagements
Qualifications:
Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management).
3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls).
Strong project management skills with a track record of managing complex projects and meeting deadlines.
Excellent organizational and communication skills.
Excellent time management abilities
Proficient in Microsoft Office Suite
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment.
Additional Requirements:
Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones
#LI-LB1
#LI-REMOTE
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs