Syneos Health® is a premier biopharmaceutical solutions organization dedicated to accelerating customer success in the ever-evolving healthcare landscape. With a workforce of 29,000 employees across 110 countries, we leverage our extensive insights and expertise to transform clinical, medical affairs, and commercial outcomes to meet modern market challenges. Our mission is to simplify and streamline processes, placing customers and patients at the core of our endeavors.
Job Overview
Position: Regulatory Consultant
Location: Gurugram, India (Hybrid)
Job ID: 25002289-IND002
Employment Type: Full-time
Job Responsibilities
As a Regulatory Consultant, you will play a pivotal role in providing regulatory and technical support for various lifecycle maintenance activities such as CMC post-approval variations, renewals, and annual reports. Your responsibilities include:
- Regulatory Submissions: Author and review Module 3 CMC sections for post-approval variations, renewals, and other maintenance activities, ensuring compliance with current regulations.
- Change Control Assessment: Evaluate change control issued by quality or regulatory departments to assess regulatory impacts and devise submission strategies.
- Research & Analysis: Conduct comprehensive research on existing product data to prepare gap analyses and contribute to regulatory submissions for IND, pre-approval packages, and product registration applications.
- Project Management: Manage day-to-day regulatory activities for assigned projects, operating within agreed-upon timelines and budget constraints.
- Cross-Functional Collaboration: Work alongside multidisciplinary project teams, acting as a subject matter expert and providing solutions to project-related challenges.
- Client Interaction: Engage with clients to discuss proposals and project statuses, and support business development efforts.
Qualifications
To excel in this role, the ideal candidate should possess:
- Experience: Minimum of 3 years in CMC post-approval variations, renewals, and lifecycle maintenance activities.
- Educational Background: An MS, M.Pharm, or PhD in a science-related field or equivalent regulatory/scientific experience.
- Submission Expertise: Proven experience in preparing regulatory submissions including post-approval CMC variations, IND, PMA, NDA, MAA, and CTD.
- Communication Skills: Excellent written and verbal communication skills are essential.
- Technical Proficiency: Strong experience with RIMS systems such as Veeva RIMS and TrackWise, along with advanced skills in Microsoft Office.
- Analytical Abilities: Strong analytical skills with meticulous attention to detail.
Why Join Syneos Health?
- Career Development: We prioritize personal and professional growth through robust training, support, and engagement.
- Inclusive Culture: Our Total Self culture fosters diversity, creativity, and a sense of belonging, creating an enriching work environment.
- Impactful Work: Join a team that is passionate about accelerating the delivery of therapies that change lives.
