We help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way. We bring together healthcare domain expertise, fit-for-purpose technology, and an agile operating model to provide a diverse range of solutions. These aim to deliver, amongst other outcomes, a personalized, scalable and omnichannel experience for patients and physicians. It’s what drives our team and our purpose to enable healthcare organizations to be future ready.
Post : Lead- Regulatory Writing
Job Description
The Regulatory Lead role is responsible for managing regulatory operations including initial submissions and life cycle management of products, ensuring regulatory compliance in all marketed regions. This includes:
• Planning and execution of new product registrations, line extensions, new indications, license renewals, variations management and label updates throughout the life cycle of a marketed product ensuring compliance with local regulations and quality system requirements.
• Preparing, reviewing, and submitting regulatory dossiers for marketing authorization (MA) applications, ensuring timely and high-quality submissions in compliance with Health Authority regulations including but not limited to US, CA, EU, LATAM, APAC, GCC, and CIS countries.
• Managing post-approval activities, preparing and submitting applications for registration and import licenses, renewals, variations and ensuring compliance and timely renewals of regulatory commitments, while working with the client, and their local affiliated as applicable.
• Building and leading excellence focused team ensuring key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency.
• Facilitating and cultivating relationships with local Regulatory Agencies/affiliates and Health Authorities to achieve successful outcomes and strategic alignment for submissions and schedules in each country.
• Ensuring Regulatory submissions and subsequent HA communication/responses within planned timelines.
• Voicing affiliate perspectives and needs to global and regional regulatory contacts.
• Maintaining regulatory tools in alignment with defined compliance metrics. Staying aware of current regulations and anticipating the implications and opportunities of changes in the regulatory environment. Communicating changes to appropriate management and cross-functional experts and implementing them locally.
• Addressing complex regulatory and business challenges, collaborating across functions and regions to drive favourable outcomes and acting as a subject matter expert, assisting team members with troubleshooting and presenting solutions to project-related problems.
• Assessing change control issued by quality or regulatory departments, evaluating regulatory impact, and developing submission strategies.
• Ensuring accurate documentation and management of regulatory activities and data, maintaining and updating local Regulatory Affairs SOPs in adherence to quality standards.
• Leading meetings with clients to discuss proposals, project status, and general business development activities.
• Developing and implementing long-term regulatory optimization and streamlining initiatives to enhance compliance and business efficiency.
Candidate Profile
• BPharm, MPharm, Pharm D, or MSc.
• 8-10 years in Regulatory Affairs and Submissions Management.
• Experience with life-cycle management activities (e.g. Europe, USA, International would be an asset)
• In Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (EU - CP, MRP, DCP, National etc.) and LCM strategies
• Familiarity with Veeva RIMS, TrackWise, and other RIMS systems.
• Strong project management and documentation skills, proactive communication approach
• Great customer service skills, able to work well and manage a team
• Advanced skills in Microsoft Office and Adobe Professional.
Additional Information
Experience : 8-10 years
Qualification : BPharm, MPharm, Pharm D, or MSc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Writing
End Date : 30th June 2025
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