[Hiring] Global Regulatory Lead Partner @Syner-G

Role Description

The Global Regulatory Lead Partner supports Global Regulatory Leads in assigned therapeutic areas and serves as the accountable global regulatory point of contact for designated products. The individual provides regulatory leadership for life‑cycle management, maintenance of established products, and execution of global regulatory submissions. This role drives results through regulatory science expertise, strong communication, and analytical capabilities, ensuring high‑quality regulatory strategies and deliverables for assigned products.

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

Key Responsibilities

• Ensure maintenance of global registrations for assigned products, including US and EU markets.
• Lead and execute regulatory activities supporting life‑cycle management, including submission strategy development, timeline definition, prioritization, assembly review, and identification of regulatory risks/challenges.
• Manage regulatory agency communications and submissions, including responses to agency questions, labeling negotiations, updates, and periodic reports.
• Coordinate SMEs to develop response strategies and author/review responses to health authority requests.
• Support labeling discussions, updates, and filings across CCDS, USPI, SmPC, and country‑specific labels.
• Provide regulatory input for annual reports, renewal applications, and aggregate safety reports (e.g., PSURs, PADERs).
• Conduct regulatory review for tender bid applications and assess country requests for registration deletions.
• Support preparation of ancillary documents required for product registrations in global markets.
• Follow through on agency commitments and ensure timely, high‑quality regulatory deliverables.
• Conduct research and review of US, EU, and other relevant regulatory guidelines, precedence, and competitive intelligence to inform regulatory strategy.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional partners to ensure alignment and execution of regulatory strategy.

Qualifications

• Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs.
• 5+ years of experience in regulatory affairs and/or regulatory framework of major health authorities.
• Experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics.
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
• Regulatory experience with pre and post approval lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Strong strategic skills and the ability to balance short-term needs with long-term vision.
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Skills and Attributes

• Excellent written and verbal communication skills.
• Strong negotiating skills and ability to think creatively and develop innovative solutions.
• Strong organizational and project management abilities.
• Strong analytical skills with high attention to detail.
• Understanding of regulatory filing requirements.
• Knowledge of ICH guidance and routine regulatory maintenance requirements.
• Ability to manage multiple priorities and work independently in a fast-paced environment.
• Proactive, detail-oriented, and self-motivated with a strong work ethic.

Benefits

• Recognition as one of BioSpace's "Best Places to Work" for the third consecutive year.
• Commitment to fostering a positive and engaging work environment.
• Emphasis on culture, career growth, and development opportunities.
• Financial rewards, leadership, and innovation.