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
Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client’s investigational, new, and marketed biologic and small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.
Key Responsibilities
Strategic CMC Leadership
• Provide regulatory strategy input for biologics and small molecules (previous experience with drug-device combination products is a plus)
• Support regulatory leads in developing contingency plans for CMC-related scenarios
• Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Submission & Documentation Excellence
• Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
• Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
Cross-Functional Collaboration
• Partner with manufacturing, quality, and external organizations to address CMC-related issues
• Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
• Support planning and execution of Health Authority meetings, including mock sessions
Process Optimization & Innovation
• Identify and implement process improvements to enhance regulatory efficiency and readiness
• Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
• Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer
Regulatory Systems & Reporting
• Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus
• Ensure audit readiness and version control through meticulous documentation and system management
Qualifications
Experience & Expertise
• 4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
• Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
• In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for biologics and small molecules
• Familiarity with upstream/downstream biologic processes and analytical methods
Skills & Attributes
• Strategic and proactive mindset with strong operational execution
• Excellent analytical, problem-solving, and negotiation skills
• Effective communicator with strong interpersonal, presentation, and leadership abilities
• Ability to manage multiple projects independently in a matrixed, multicultural environment
• Proficiency in Microsoft Office Suite and regulatory systems
Education
• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
• Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
• RAC certification is a plus
Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.
#LI-REMOTE
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs