Job Summary Table of Regulatory Project Manager

Regulatory Project Manager Career Opportunity

Are you an experienced Regulatory Project Manager looking to advance your career in the pharmaceutical industry? Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is seeking a talented professional to join their dynamic team. This role offers an exceptional opportunity to contribute to groundbreaking pharmaceutical developments while managing regulatory submissions on a global scale.

Job Description Summary

The Regulatory Project Manager at Syneos Health will oversee day-to-day management of regulatory projects, coordinate with cross-functional teams, and serve as the key liaison between clients and regulatory authorities. This position requires expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines, making it perfect for professionals with extensive pharmaceutical industry experience looking to make a significant impact in bringing therapies to market.

Key Responsibilities for Regulatory Project Managers

The successful candidate will take on numerous critical responsibilities that directly impact the regulatory success of pharmaceutical products:

• Plan and manage regulatory submissions across assigned regions and countries, ensuring compliance with all applicable regulations
• Lead project teams through the entire submission lifecycle from preparation to approval
• Develop, review, and monitor project budgets while reviewing client invoicing processes
• Serve as the primary point of contact for both clients and regulatory authorities
• Provide strategic and operational regulatory advice to internal teams and clients
• Arrange, conduct, and document client and regulatory agency meetings
• Prepare IND applications, product registration dossiers, clinical reports, and other critical regulatory documents
• Manage teams responsible for preparation of regulatory submissions for INDs, product registrations, and post-approval activities
• Contribute to quality improvement initiatives to enhance operational efficiency
• Participate in the development of regulatory systems and infrastructure
• Represent Syneos Health at industry events, potentially speaking at seminars or authoring articles for trade publications
• Develop innovative solutions to complex regulatory challenges
• Provide specialized training to other departments in areas of regulatory expertise

Benefits and Perks

Syneos Health offers a competitive benefits package designed to support their employees’ total wellbeing:

• Comprehensive health benefits including medical, dental, and vision coverage
• 401(k) with company match to help build your financial future
• Eligibility to participate in the Employee Stock Purchase Plan
• Performance-based commissions and bonuses tied to both company and individual achievements
• Flexible paid time off (PTO) and sick time policies that respect work-life balance
• Company car or car allowance for eligible positions
• Career development opportunities within a global organization of 29,000 employees across 110 countries

Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company translates unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Their innovative Clinical Development model places both customers and patients at the center of everything they do.

With an impressive track record, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites and 675,000+ trial patients in the past five years.

Company Culture

At Syneos Health, the “Total Self” culture allows employees to authentically be themselves. This unique culture unites the global team and demonstrates the company’s dedication to taking care of its people. Syneos Health continuously builds an environment where everyone belongs by bringing together diverse thoughts, backgrounds, cultures, and perspectives.

The organization is passionate about developing its people through comprehensive career development programs, supportive line management, technical and therapeutic area training, peer recognition initiatives, and competitive total rewards programs.

Career Growth Opportunities for Regulatory Project Managers

Joining Syneos Health as a Regulatory Project Manager opens doors to numerous growth opportunities. With operations in 110 countries and continuous work with innovative pharmaceutical products, professionals can expand their expertise across therapeutic areas, regulatory frameworks, and global markets. The company’s commitment to employee development ensures that talented individuals can advance their careers while making meaningful contributions to healthcare innovation.

Diversity, Equity, Inclusion, and Belonging

Syneos Health is committed to creating an environment where diversity thrives and all employees feel valued. The company believes that bringing together different perspectives creates stronger solutions for clients and better outcomes for patients worldwide. Their commitment to diversity extends beyond their workforce to how they approach clinical trials and patient engagement.

Equal Opportunity Statement

Syneos Health is firmly committed to providing equal employment opportunities to all qualified individuals regardless of race, color, religion, gender, gender identity, sexual orientation, national origin, age, disability status, protected veteran status, or any other characteristic protected by law. The company provides reasonable accommodations to assist employees or applicants in performing essential job functions.

Remote Work Policy

While specific remote work details for this position aren’t explicitly stated, Syneos Health operates globally and has demonstrated flexibility in work arrangements. The company focuses on results and collaboration, utilizing modern technologies to connect teams across geographic boundaries.

Application Process

To apply for the Regulatory Project Manager position at Syneos Health:

1. Review the full job description and requirements to ensure alignment with your qualifications
2. Submit your application through the provided LinkedIn job posting link
3. Prepare for a potential multi-stage interview process that may include technical assessments and cultural fit discussions
4. Successful candidates will be contacted for next steps in the hiring process

Qualifications Required for Regulatory Project Managers

To excel in this role, candidates should possess:

• BS degree, preferably in a science-related field or equivalent experience
• Minimum 8 years of experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry
• 7-10 years of participation in cross-functional project management activities
• Expertise in global regulatory submissions with strong knowledge of FDA, EMA, and ICH guidelines
• Experience managing multiple Marketing Applications and/or LCM submissions simultaneously across multiple regions
• Comprehensive regulatory knowledge of pharmaceutical and/or medical device product development
• Excellent interpersonal and communication skills, both written and verbal
• Strong project management, budgeting, and quality management capabilities
• Advanced proficiency in Microsoft Office applications
• Analytical mindset with exceptional attention to detail
• Ability to work concurrently on multiple projects with varying instructions
• Fluency in English (speaking, writing, and reading)

FAQs About Regulatory Project Manager Positions

What makes Syneos Health unique in the pharmaceutical industry?

Syneos Health distinguishes itself through its fully integrated biopharmaceutical solutions approach, combining clinical, medical affairs, and commercial insights to accelerate customer success in bringing therapies to market.

What career progression can I expect as a Regulatory Project Manager?

Successful Regulatory Project Managers often advance to Senior Regulatory Affairs positions, Regulatory Affairs Directors, or specialized roles focused on specific therapeutic areas or global regions.

How does Syneos Health support professional development?

The company offers career development programs, technical and therapeutic area training, mentorship opportunities, and exposure to diverse projects across the pharmaceutical development spectrum.

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