Job Title: Regulatory Consultant (EU Market Experience)
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25001352
Updated: Today
Job Responsibilities:
Regulatory Submission and Compliance:
Conduct research of existing product data to meet global or regional regulatory requirements and prepare gap analyses, product development plans, and regulatory submissions.
Contribute to or prepare administrative and technical components for regulatory submissions, including IND, pre-approval submission packages, product registration applications, and post-approval maintenance.
Prepare briefing packages for regulatory agency meetings or scientific advice and assist with agency interactions.
Independently manage and operationalize regulatory activities for assigned projects, ensuring adherence to timelines, budgets, and scope.
Project and Team Collaboration:
Serve as a subject matter expert (SME) and provide troubleshooting support to the project team, offering solutions to regulatory challenges.
Collaborate as regulatory support on multidisciplinary project teams, contributing to product development throughout the product lifecycle.
Ensure compliance with global regulatory requirements and company policies.
Contribute to internal and external audits, regulatory support for cross-functional initiatives, and process documentation.
Client and Business Development Support:
Prepare estimates for regulatory services as part of proposals.
Support client meetings to discuss ongoing project status and business development activities.
Training and Process Improvement:
Prepare training materials and share best practices in the regulatory field, both internally and externally.
Contribute to the creation and maintenance of SOPs and other process-related documentation.
Maintain individual training records and ensure completion of required training.
Qualifications:
Required:
Experience: Minimum of 3 years of experience in the CMC module 3 for the EU market.
Education: BS or PhD degree, preferably in a science-related field, or equivalent experience in science/regulatory/medical writing.
Experience in Submissions: Demonstrated experience in contributing to regulatory submissions, such as IND, PMA, NDA, MAA, and CTD, including electronic submissions.
Skills:
Strong interpersonal and communication skills (written and verbal).
Excellent customer service skills with the ability to work both independently and as part of a team.
Advanced proficiency in Microsoft Office applications.
Strong analytical skills, attention to detail, and the ability to multitask across multiple projects.
Fluent in English (both spoken and written).
Desirable:
Experience in pharmaceutical or medical device-related fields.
Good quality management skills and the ability to establish project standards.
About Syneos Health:
Syneos Health has worked with 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites. Join Syneos Health and take the initiative in an environment that challenges the status quo.
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