Associate/Director of Regulatory Affairs (remote US or Canada)

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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