Syneos Health® is a prominent biopharmaceutical solutions organization, dedicated to accelerating customer success through an integrated clinical development model. With over 29,000 employees across 110 countries, we place the customer and patient at the heart of what we do. Our mission is to innovate and streamline our processes, making it easier for our clients to navigate the complexities of drug development.
At Syneos Health, we pride ourselves on cultivating a diverse and inclusive work culture, fostering an environment where every individual feels valued and empowered to be their authentic selves. We believe in investing in our people through career development, mentorship programs, and a total rewards framework.
Job Summary
Syneos Health is seeking a Regulatory Associate or Sr Regulatory Associate to join our team. In this role, you will perform detailed and confidential project-related duties directly focused on regulatory submissions and compliance. Working under limited supervision, you will contribute significantly to ensuring that our regulatory applications meet stringent government regulations.
Key Responsibilities
- Regulatory Submissions: Prepare and submit components of Investigational New Drug applications (INDs), New Drug Applications (NDAs), and lifecycle maintenance applications to ensure compliance.
- Module Preparation: Independently prepare Module 3 sections for post-approval changes, renewals, and annual reports.
- Quality Control: Conduct quality control reviews of regulatory documents and track them until final submission.
- Project Involvement: Attend client meetings to help build strong relationships and contribute to project success.
- Mentorship: Assist in training and mentoring junior team members to enhance team capabilities.
- Database Maintenance: Maintain and update regulatory databases according to Syneos Health and client requirements.
Qualifications
- Education: MS/M.Pharm or an equivalent combination of education and experience.
- Experience: Minimum of 6 months for Regulatory Associate and 1.5 years for the Sr Regulatory Associate role.
- Technical Skills: Proficiency in Microsoft Office Applications and familiarity with RIM systems such as Veeva RIMS and Trackwise is preferred.
- Skills: Strong analytical abilities, excellent communication skills, and the ability to work independently on multiple projects concurrently.
- Language: Fluency in English (reading, writing, and speaking) is essential.
Why Join Syneos Health?
- Career Development: Benefit from continued professional growth through training and career progression opportunities.
- Inclusive Culture: Join a workplace where diversity of thought is valued, and every voice matters.
- Impactful Work: Contribute to the development of therapies that help improve lives globally.
How to Apply
