Regulatory Affairs Consultant I

POSITION OVERVIEW:

Syner-G BioPharma Group is seeking a Regulatory Affairs Consultant to support a global pharmaceutical client in the area of Chemistry, Manufacturing, and Controls (CMC), with a focus on post-approval regulatory submissions. This remote role, based in Bangalore, Chennai, Hyderabad, or Mumbai, involves providing strategic regulatory guidance and operational support to ensure compliance with FDA, EMA, and global regulatory requirements. The ideal candidate will bring strong scientific acumen, regulatory expertise, and leadership capabilities.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Lead and manage regulatory milestones for assigned products throughout the product lifecycle
• Contribute to strategic regulatory discussions and decision-making processes
• Develop and execute CMC regulatory strategies for post-approval pharmaceutical products in compliance with US, EMA, and global regulations
• Author and review global CMC submissions and supporting documentation for post-approval supplements, variations, and responses to health authority queries
• Collaborate with internal teams and external partners to ensure compliant execution of change management activities
• Coordinate timely and accurate responses to regulatory authority questions (RTQs) related to CMC content
• Manage regulatory operational activities including organizing, tracking, and preparing submissions for publishing
• Conduct regulatory change control assessments and strategize post-approval implementation and reporting
• Review technical documents such as certificates of analysis, analytical methods, specifications, and stability data
• Prepare and support CMC documentation for post-approval submissions, new market registrations, and source of supply changes
• Maintain up-to-date knowledge of FDA, EU, and global regulations and guidance relevant to marketed products
• Identify and communicate potential regulatory risks and mitigation strategies
• Lead or support a team of 2 to 4 regulatory professionals, providing guidance and oversight on project execution
• Potentially contribute to pre-approval submissions (IND/CTA/IMPD) depending on experience

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s or Master’s degree in Pharmacy, Biological Sciences, Engineering, or a related field. Advanced degree preferred

Experience:

• Minimum 7 years of experience in CMC post-approval regulatory submissions or related fields such as manufacturing, quality control, or analytical development
• At least 5 years of experience authoring and reviewing CMC sections in Modules 1, 2, and 3 for post-approval filings
• Strong knowledge of US and European regulatory frameworks and ICH guidelines
• Experience in pharmaceutical development, drug product specifications, and stability programs
• Familiarity with cGMP environments and regulatory systems/tools (e.g., EDMS, Veeva Vault, Trackwise) is a plus
• Prior supervisory or team leadership experience is preferred

Skills and Attributes:

• Excellent written and verbal communication skills
• Strong organizational and project management abilities
• Ability to manage multiple priorities and work independently in a fast-paced environment
• Proactive, detail-oriented, and self-motivated with a strong work ethic

Work Location:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.