Regulatory Consultant
2 weeks ago
Syneos Health, a leading biopharmaceutical solutions organization, is seeking a highly skilled Regulatory Consultant to join our team.
About Syneos HealthWe accelerate customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model puts the customer and patient at the center of everything we do.
We are looking for a talented individual to collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile, driven to accelerate the delivery of therapies, and passionate about changing lives.
Why Work at Syneos Health?
- We offer career development and progression through supportive line management, technical training, peer recognition, and total rewards.
- We foster a Total Self culture where you can authentically be yourself, taking care of our people and building a company everyone wants to work for.
- We bring together diversity of thoughts, backgrounds, cultures, and perspectives to create a workplace where everyone feels like they belong.
- Conduct research on existing product data relative to global or regional regulatory requirements for gap analyses, product development plans, and submissions.
- Prepare administrative and technical components of regulatory agency submissions, including IND, PMA, NDA, MAA, and CTD.
- Manage day-to-day regulatory activities according to agreed timelines, scope, budget, and strategies.
- Participate in multidisciplinary project teams to develop products throughout their life cycle.
- Act as a subject matter expert, helping team members with troubleshooting and presenting solutions.
- Prepare estimates for conducting regulatory services.
- Support meetings with clients to discuss proposals and ongoing projects.
- Ensure compliance with global regulatory requirements and company policies.
- Prepare training materials and share best practices in the regulatory area.
- Participate in internal or external project audits and cross-functional initiatives.
- Maintain individual training records and complete required training.
- BS or PhD degree in a science-related field or equivalent experience in science/regulatory/medical writing-related fields.
- Experience in contributing to regulatory submissions, including electronic submissions.
- Excellent communication and interpersonal skills, with written and verbal fluency.
- Customer service skills, with ability to work independently and as part of a team.
- Quality management skills, with advanced Microsoft Office skills.
- Ability to interact with staff from multiple departments and offices.
- Good initiative, adaptability, and proactivity.
- Strong analytical skills, with attention to detail.
- Ability to work concurrently on projects with specific instructions.
- Fluent English speaker, writer, and reader.
As a Regulatory Consultant, you will have an estimated salary of $85,000-$110,000 per year, depending on location and experience. We also offer benefits such as career development opportunities, comprehensive health insurance, retirement savings plan, and paid time off.
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