Work From Home Regulatory Affairs Hiring at Syneos Health

Syneos Health Regulatory Associate/Sr. Regulatory Associate (Work from Home)

Are you looking for a work-from-home opportunity in regulatory affairs? Syneos Health, a global biopharmaceutical solutions leader, hires experienced professionals for the Regulatory Associate and Senior Regulatory Associate positions. If you have a background in M.Pharm/MS with at least 6 months of experience, this is your chance to advance your career in a dynamic, remote work environment.

Job Responsibilities

As a Regulatory Associate/Senior Regulatory Associate, you will be responsible for:

• Essential Functions

  For non-complex submissions, independently fulfil the following responsibilities. For complex submissions, fulfil the following redutiesnder the supervision and with guidance from more senior regulatory colleagues:

  • Prepares Module 3 sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities according to current government regulations and guidelines
  • Prepares and submits complete applications or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
  • Experience performing activities in Veeva RIMS, including creating objectives and submission content plans, would be preferred.
  • Undertakes information processing activities with extremely high reliability, high quality, and tight timelines according to standard processes and operating procedures.
  • Undertake project-specific activities with minimal supervision from senior colleagues regarding cost and time estimates/contracts.
  • Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.
  • Conducts Quality Control reviews of documents and sends them out for review, tracking them until final submission or delivery to the client.
  • Attends client meetings as needed and builds client relationships in support of projects and deliverables.
  • Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with the project manager and director for project coordination.
  • Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.
  • Assists in training and mentoring team members depending on project requirements.
  • Maintain individual training records (Syneos Health or client-related) and complete all designated required training.

Qualifications & Skills Required

• Educational Qualification: MS/M.Pharm or an equivalent combination of education and experience.
• Experience:
  • Regulatory Associate: Minimum 6 months of experience.
  • Senior Regulatory Associate: Minimum 1.5 years of experience.
• Proficiency in Microsoft Office applications and regulatory systems like Veeva RIMS and Trackwise (preferred).
• Strong analytical and communication skills.
• Ability to work independently and manage multiple regulatory projects.
• Fluent in written and spoken English.

About Syneos Health

With a presence in 110+ countries and a workforce of over 29,000 employees, Syneos Health has brought 94% of FDA-approved drugs to market in the last five years. Our collaborative work culture fosters innovation and excellence, making Syneos Health a preferred employer in the biopharmaceutical industry.

How to Apply?

If you are interested in joining Syneos Health’s regulatory affairs team, apply now by clicking the link below:

➡ Apply Here

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