Manager, Regulatory Strategy

Camargo Pharmaceutical Services is seeking an experienced Manager, Regulatory Strategy with experience in providing high-quality scientific writing and advanced scientific research and writing expertise for our cross-functional project teams overlaid with US, Europe and/or Asia regulatory understanding. These positions are located in either our Cincinnati, OH, Durham, NC, Montreal, Quebec offices.

Since Camargo Pharmaceutical Services is the leading expert in drug development, you will provide expertise and customer-centric professionalism to our clients, which range from small biotech firms to large, established pharmaceutical companies.

This position is a natural fit if you possess well-developed and demonstrable writing skills, understand strategic communications, and can “simplify the complex.” Strategic/critical thinking skills, as well as initiative, are a must for this role! If you are inherently inquisitive and strategic, then Camargo is the place for you!

Qualifications:

• Ph.D. in a Scientific or life sciences field with minimum 5+ years' drug development/industry experience
• Demonstrated knowledge of the research process and direct research experience
• Demonstrated writing skills

What You’ll Do:

As the Manager of Regulatory Science, you will independently create high-quality, complex summary documents in support of client work products and regulatory submissions, including Strategic Assessments; Go-no-Go Reports; Briefing Packages; Clinical Study Synopses/Protocols; Research Papers; Regulatory Documents for INDs, NDAs, ANDAs and other regulatory submissions; Abstracts; Posters; Manuscripts; Case Report Forms. You’ll conduct substantive research to test and substantiate the viability of strategic options, presents options, and makes/defends recommendations, proactively troubleshoot problems, identify resources and actively work to bring resolution. As a Manager of Regulatory Science, you’ll get the opportunity to participate in meetings with Regulatory bodies. You’ll function as Team Lead on complex projects, coordinating a cross-functional team for successful completion of projects within timelines and budgets. We’ll rely on you to actively coach Regulatory Affairs Specialists and Research Scientists to build the talent and skills needed for personal and professional success.

Why Join Us?

At Camargo, we are passionate about science and drug development. Our goal is to assist our partnering companies to fill their financial gaps, dig deeper to identify and develop viable products and provide the optimal benefits to patients. There are no boundaries to your involvement and the part that you can play in growing the company and developing new skills. Our culture for learning and sharing is unique. The open and collaborative atmosphere and opportunity for growth through interactions is one of the many reasons our team is so dynamic and successful.

Camargo is proud of our cross-functional teams and we cultivate a learning environment that supports one another. We offer a rich benefits package including medical, dental, and vision coverage, life insurance, short-term and long-term disability, vacation days and company paid holidays among other perks.

About Our Company

We have proudly earned our reputation for insight-driven and creatively bold solutions to help companies navigate complex, customized regulatory pathways, including the 505(b)(2) regulatory pathway, and have established ourselves as a full-service partner of choice for pharmaceutical product development companies in 25 countries around the globe. Camargo is a fast-growing company that upholds a culture centered on high performance, is attentive to improving quality of work life, and offers rewards commensurate with achievement. We have only scratched the surface with our ability to penetrate innovative markets and are actively looking to capture more market share. We are headquartered in Cincinnati, OH, with offices in Durham, NC, and Montreal, Quebec

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