Manager/ Senior Manager - Regulatory Affairs

BRIEF TEAM/DEPARTMENT DESCRIPTION:

Team is responsible for designing and executing global regulatory strategies to ensure the timely approval of a diverse portfolio of pharmaceutical products and the lifecycle maintenance of these products. The team works across multiple complex projects, facilitating various types of submissions to agencies like the FDA, EMA, MHRA or EU National Authorities, HC, and other international authorities, by ensuring compliance with evolving regulations.

PRINCIPLE RESPONSIBILITIES:

• Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, Canada markets by managing the submissions including Pre-INDs, Scientific Advice (ScAs), Pediatric Investigation Plans (PIPs), and Notified Body Opinions etc.
• Oversee the end-to-end preparation, review, and filing of regulatory dossiers (NDAs, NDSs, and MAAs (CP, DCP, MRP, NPs) etc. to ensure timely submissions.
• Lead cross-functional team discussions to align submission strategies, define priorities, and establish realistic timelines based on evolving regulatory requirements.
• Perform global regulatory due diligence and comprehensive gap assessments to identify potential risks and mitigation strategies for US, EU, UK, and Canada filings.
• Monitor evolving, region-specific regulations and proactively provide strategic guidance to cross-functional teams to ensure compliance.
• Manage the review and approval of artwork, including SPCs and PILs, ensuring adherence to current standards.
• Manage regulatory readiness for launch in compliance with evolving EU and UK regulations.
• Hands on experience in handling activities related to xEVMPD, RIMS, PLM, IRIS, etc.
• Support the assessment of promotional materials to ensure regulatory compliance, as needed.
• Direct post-approval regulatory activities, including supplements, variations, and renewals, to ensure continuous compliance throughout the product lifecycle, as needed.

CORE RESPONSIBILITIES:

• Lead the development and execution of end-to-end regulatory strategies for pharmaceutical products across the US, EU, UK, Canada markets.
• Ensuring successful submissions including Pre-INDs, ScAs, NDAs, NDSs, and MAAs (CPs, DCPs, MRPs, NPs) etc.
• Manage Health Authority (FDA, EMA, MHRA or National Authorities, HC) communications and secure timely/required feedback and approvals.
• Provide regulatory support for international territories, ensuring compliance and continuity in lifecycle maintenance.
• Oversee lifecycle management activities, including supplements, variations, and other post-approval regulatory submissions on need basis.

Qualifications and Education Requirements

• 12+ years of experience in pharmaceutical regulatory affairs for US, EU, UK, Canada markets
• Master of Science in Pharmaceuticals or Equivalent
• Regulatory Affairs exposure to China and Emerging markets would be considered a plus
• Ability to perform under pressure with limited resources
• Excellent communication and presentation skills in English
• Strong writing analytical and problem-solving abilities