Join as a Regulatory Consultant at Syneos Health
About Syneos Health®: Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Job Overview:
- Title: Regulatory Consultant
- Location: India-Asia Pacific – IND-Gurugram-Hybrid
- Job ID: 25002289
Why Syneos Health:
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Summary:
Job Responsibilities:
- Providing regulatory and technical support for assigned CMC post-approval variations, renewals, annual reports, and other lifecycle maintenance activities.
- Managing delivery of regulatory activities according to timelines and budgets.
- Participating as regulatory support on multidisciplinary project teams.
- Preparing estimates for conducting regulatory services.
- Ensuring compliance with global regulatory requirements and company policies.
- Providing support in oversight to team members.
Qualifications:
- Minimum of 3 years in CMC post-approval variation renewals, annual reports, legal entity name changes, and other lifecycle maintenance activities.
- MS, M.Pharm or PhD degree in a science-related field.
- Demonstrated experience in contributing to regulatory submissions.
- Advanced skills in Microsoft Office Applications.
Get to know Syneos Health:
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
Keywords: regulatory consultant, healthcare, biopharmaceutical, regulatory submissions, Pharma jobs, chemistry jobs, Regulatory Consultant, Syneos Health
