Associate/Director of Regulatory Affairs (remote US or Canada)
United States of America, Remote Additional Locations Ontario, Remote Job ID R0000030809 Category Consulting Date Posted 01/24/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Exciting opportunity to join Parexel as an Associate/Director of Regulatory Affairs!
As an Associate/Director of Regulatory Affairs, you will play a pivotal role in bridging regulatory expertise with business growth, combining strategic thinking with hands-on management to drive success for both clients and Parexel. This position requires a blend of regulatory acumen, leadership skills, and business savvy to navigate the complex landscape of drug and biologic product development and approval processes.
This role offers you the opportunity to:
Leverage your extensive regulatory knowledge
Lead an outstanding team
Make a significant impact
Contribute to Parexel's continued success
This position requires a seasoned professional with deep expertise in regulatory affairs with a focus on regulatory authoring and FDA regulatory processes.
The ideal candidate will possess exceptional leadership skills and demonstrate the ability to provide strategic oversight while offering guidance on developing and managing regulatory documentation for submissions. A keen balance between high-level strategic thinking and detail-oriented execution in regulatory writing is essential for success in this position.
You will:
Use your extensive Regulatory and Product Development knowledge to oversee a team of regulatory authors for all phases applications in the US.
Lead a team of Regulatory Affairs professionals, focusing on technical writing skills and high-quality with a focus on clinical/non-clinical modules for submissions.
Provide strategic guidance on crafting compelling regulatory documents for submissions
Oversee preparation of, review, and/or writing of core regulatory documents for INDs, NDAs, BLAs and other FDA related documentation or correspondence
Perform high-level review of regulatory submissions as required
Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on regulatory guidelines and requirements.
Provide mentorship and support career growth opportunities for direct reports.
Interact with various stakeholders around the world, including the writing team, subject matter experts, project leadership, and the Sponsor with a focus on high-quality deliverables.
Create efficient workflows, timelines, and demonstrate strong project management skills for timely, high-quality deliverables.
Facilitate effective coordination and communication among stakeholders to achieve project goals.
Collaborate with cross-functional teams to ensure alignment of regulatory strategy with overall product development goals.
Implement strategies to mitigate risks and address potential challenges in project execution and staff allocation, resourcing needs.
Facilitate staff development plans and coordinates with project staffing for appropriate utilization and skill expansion.
Participate in project scoping calls, proposal preparation, Bid Defense Meetings, and account planning/oversight for key clients.
Actively prospect and leverages new business opportunities in collaboration with Account Management
Lead team meetings and communicate organizational vision and values to staff and promotes effective information flow.
Skills:
Management and leadership skills with proven experience coaching, motivating, developing, and retaining high performing regulatory professionals.
Consulting skills
Project management knowledge
Influencing others
Client-focused approach to work
Networking
Results orientation
Business analysis
Excellent interpersonal and intercultural communication skills, both written and verbal
Teamwork and collaboration
Critical thinking and problem-solving skills
Holding people accountable
Operational leadership
Leading change
Strategic business thinking
Ability to successfully work in a fast-paced, demanding and collaborative environment
Strong organization and planning skills with an attention to detail and ability to handle multiple tasks with accuracy.
To ensure success, you will have:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD) Preferred
Minimum 8-10 years related Regulatory Affairs experience in the life sciences or consulting industries with a strong knowledge of regulatory authoring with an emphasis on clinical and/or nonclinical modules
Minimum 4-6 years of experience in people management and leadership experience regulatory functions for an Associate Director, Regulatory Affairs and 8+ years for a Director, Regulatory Affairs
Previous CRO or Consulting experience highly preferred
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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