Regulatory Consultant
WFA Digital Insight
The demand for regulatory specialists in the life sciences sector has seen significant growth, with a focus on compliance and submission management. As the industry continues to evolve, companies like Syneos Health are at the forefront, driving innovation and customer success. With a strong background in regulatory affairs, Excel skills, and experience in CMC modules, candidates can stand out in this competitive market. Before applying, it's crucial to understand the company's commitment to building an inclusive culture and its purpose-driven approach. The regulatory landscape is complex, and candidates should be prepared to navigate this environment effectively.
Job Description
About the Role
The Regulatory Consultant position at Syneos Health India Private Limited is a critical role that involves managing regulatory submissions, ensuring compliance, and driving customer success in the life sciences sector. As a key member of the Clinical Solutions team, the successful candidate will collaborate with cross-functional teams, applying their expertise to shape solutions that impact patient progress. With a strong focus on regulatory affairs, the ideal candidate will have experience in CMC modules, authoring of CMC sections, and lifecycle management activities.The team at Syneos Health is passionate about developing people, through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards programs. The company is committed to building an inclusive culture, where colleagues can authentically be themselves, and is driven to deliver for customers, patients, and the future of healthcare.
What You Will Do
- Conduct research of existing product data relative to global or regional regulatory requirements
- Prepare administrative and technical components of regulatory agency submissions
- Manage day-to-day regulatory activities for assigned projects according to agreed timelines and strategies
- Participate as regulatory support on multidisciplinary project teams
- Act as a subject matter expert, helping team members with troubleshooting activities
- Prepare estimates for conducting regulatory services as part of proposals
- Support meetings with clients to discuss proposals and project status
- Ensure compliance with global regulatory requirements and company policies
- Prepare training materials and share best practices in the regulatory area
- Participate in internal or external project audits and cross-functional initiatives
- Contribute to the creation and maintenance of SOPs and process-related documentation
What We Are Looking For
- Minimum 4-5 years of experience in regulatory affairs
- MPharm degree
- Experience with CMC modules and authoring of CMC sections
- EU and GCC market experience
- Strong Excel skills
- Ability to work independently and as part of a team
- Excellent communication and problem-solving skills
- Experience with non-complex and complex submissions
Nice to Have
- Experience with regulatory agency interactions
- Knowledge of regulatory requirements for different markets
- Familiarity with lifecycle management activities
- Certification in regulatory affairs
- Experience with project management tools
Benefits and Perks
- Opportunity to work with a leading fully-integrated life sciences services organization
- Collaborative and inclusive work environment
- Career development and progression opportunities
- Supportive line management and mentorship
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Flexible working arrangements and remote work options
- Access to cutting-edge technologies and tools
- Comprehensive health and wellness programs
How to Stand Out
- Ensure your resume highlights specific experience with regulatory submissions and compliance in the life sciences sector.
- Prepare examples of how you've managed day-to-day regulatory activities and ensured timely submissions.
- Familiarize yourself with Syneos Health's company culture and values to demonstrate your fit during the interview process.
- Develop a strong understanding of CMC modules and authoring of CMC sections to stand out as a candidate.
- Be prepared to discuss your experience with Excel and other regulatory tools, highlighting your technical skills.
- Research the company's approach to regulatory affairs and be ready to ask informed questions during the interview.
- Consider creating a portfolio that showcases your regulatory experience and achievements to share with the interviewer.
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