Job Title: Regulatory Consultant
Job Location: India - Asia Pacific - Home-Based
Company Overview
Syneos Health is a global leader in biopharmaceutical solutions, offering integrated services across clinical development, medical affairs, and commercial strategy to accelerate the delivery of therapies. The company emphasizes customer success, innovation, and operational efficiency, working in over 110 countries.
Role Summary
As a Regulatory Consultant, you will independently handle the preparation and submission of regulatory documents, including INDs, pre-approval packages, and post-approval submissions. You will work with multidisciplinary project teams, contributing to regulatory support for product development and maintaining regulatory compliance.
Key Responsibilities
Conduct research to assess existing product data and prepare gap analyses, product development plans, and regulatory submissions.
Contribute to or prepare technical components of regulatory submissions for IND, product registration applications, and post-approval maintenance.
Manage and operationalize regulatory activities for assigned projects, ensuring compliance with timelines, scope, budget, and strategy.
Act as a regulatory support expert, providing troubleshooting solutions and guidance to team members.
Contribute to business development by supporting client meetings and proposals.
Ensure compliance with global regulatory requirements and company policies.
Prepare training materials and share best practices internally and externally.
Participate in internal or external project audits and cross-functional initiatives.
Contribute to the creation or maintenance of SOPs and process documentation.
Support oversight of team members in executing their responsibilities.
Provide regulatory support for change controls assessments and submission strategy preparation.
Qualifications
Required
Education: BS or PhD degree, preferably in a science-related field, or equivalent experience in regulatory, science, or medical writing-related fields.
Experience:
Experience with regulatory submissions such as IND, PMA, NDA, MAA, and CTD.
Moderate pharmaceutical/medical device experience.
Experience with electronic submissions and regulatory compliance.
Skills:
Strong interpersonal and communication skills (written and verbal).
Customer service-oriented, with the ability to work independently or as part of a team.
Good quality management, initiative, adaptability, and pro-activity.
Advanced proficiency in Microsoft Office Applications.
Strong analytical skills and attention to detail.
Ability to manage multiple projects concurrently.
Preferred
Experience in Life Cycle Management (LCM) and post-approval submissions for global regions, particularly ROW/EU.
Experience supporting regulatory assessments and strategy for change controls.
Work Environment
Syneos Health offers a dynamic, diverse, and supportive environment, promoting Total Self culture, career development, and ongoing employee engagement. The company emphasizes a team-oriented approach and works to create a workplace where everyone feels a sense of belonging.
How to Apply
Interested candidates can apply through the Syneos Health career portal.
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