Regulatory Manager

🔥 1 minute ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Research existing product data against global or regional regulatory requirements • Prepare gap analyses, product development plans, and regulatory submissions • Prepare administrative and technical components of submissions for INDs, pre-approval packages, product registrations, and post-approval maintenance • Prepare briefing packages for regulatory agency meetings or scientific advice • Contribute to and support regulatory agency interactions • Manage and operationalize day-to-day regulatory activities within timelines, scope, budgets, and strategies • Provide regulatory support on multidisciplinary product development teams throughout the product life cycle • Act as a subject matter expert and troubleshoot project-related issues • Prepare estimates for regulatory services in proposals • Support client meetings concerning proposals, project status, and business development • Ensure compliance with global regulatory requirements and company policies and processes • Prepare training materials and share regulatory best practices internally and externally • Participate in internal and external project audits • Support internal cross-functional initiatives • Create and maintain SOPs and process documentation • Provide oversight support to team members executing project responsibilities • Identify when additional line support is needed • Maintain individual training records and complete required training

🎯 Requirements

• Minimum 10+ years of experience in regulatory affairs • Functional lead experience leading a team • Risk assessment capability, strategic thinking, decision-making, and project leadership • Experience handling internal and external stakeholders • M. Pharm degree • Experience with CMC Module 3 • Experience authoring CMC sections of post-approval variations and life cycle management activities • EU and GCC market experience • Master's degree, preferably in a science-related field, or equivalent experience in a science/regulatory/medical writing-related field • Moderate pharmaceutical/medical device-related experience • Experience contributing to regulatory submissions such as IND, PMA, NDA, MAA, and CTD, including electronic submissions • Excellent written and verbal communication skills • Excellent customer service skills and ability to work independently and as part of a team • Good quality management skills • Advanced Microsoft Office skills • Ability to interact with staff from multiple departments and offices to establish project standards • Initiative, adaptability, and proactivity • Strong analytical skills and attention to detail • Ability to work concurrently on multiple projects with differing instructions • Fluency in spoken, written, and read English

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate