Syneos Health WFH Opportunity in Regulatory Affairs

Are you a regulatory professional looking to advance your career in the biopharmaceutical industry? Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is hiring for the role of Regulatory Associate/Sr Regulatory Associate. This is a home-based position in India, offering an excellent opportunity to work with a global team dedicated to accelerating customer success and improving patient outcomes.

About Syneos Health

Syneos Health® is a trusted name in the biopharmaceutical industry, known for its integrated clinical, medical affairs, and commercial solutions. With over 29,000 employees across 110 countries, Syneos Health is committed to simplifying and streamlining processes to deliver therapies faster and more efficiently.

The company’s Clinical Development model places the customer and patient at the center of everything they do. By fostering a culture of collaboration, innovation, and inclusivity, Syneos Health ensures that every team member feels valued and empowered.

Why Join Syneos Health?

• Career Development: Opportunities for growth, progression, and technical training.
• Total Self Culture: A supportive environment where you can authentically be yourself.
• Global Impact: Work on projects that contribute to the development of life-changing therapies.
• Diversity and Inclusion: A workplace that celebrates diverse thoughts, backgrounds, and perspectives.

Job Description

As a Regulatory Associate/Sr Regulatory Associate, you will play a key role in ensuring compliance with government regulations and guidelines. Your responsibilities will include:

Key Responsibilities

• Prepare Module 3 sections for post-approval CMC variations, renewals, annual reports, and other lifecycle maintenance activities.
• Prepare and submit IND, marketing, and lifecycle maintenance applications to ensure regulatory compliance.
• Utilize Veeva RIMS for creating objectives and submission content plans (preferred).
• Conduct Quality Control reviews of documents and track them until final submission.
• Attend client meetings and build strong client relationships to support project deliverables.
• Train and mentor team members as needed.
• Maintain regulatory databases and ensure compliance with Syneos Health and client requirements.
• Identify risks to project delivery and escalate issues appropriately.

Qualifications

• Education: MS/M.Pharm or equivalent combination of education and experience.
• Experience:
  • Regulatory Associate: Minimum 6 months of experience.
  • Sr Regulatory Associate: Minimum 1.5 years of experience.
• Skills:
  • Advanced proficiency in Microsoft Office Applications.
  • Hands-on experience with RIM systems like Veeva RIMS and Trackwise (preferred).
  • Strong analytical and interpersonal skills.
  • Ability to work independently and manage multiple projects with specific instructions.
  • Fluent in English (speaking, writing, and reading).

Application Link