Regulatory Affairs Manager
3 hours ago
Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission timelines are met as per business needs and agency expectations. 3. Agency Engagement & Partner Coordination • Act as the primary point of contact for Health Authorities in these regions. • Lead technical and administrative discussions with regulatory agencies to facilitate approvals. • Collaborate with regional distributors/partners for local submissions and regulatory intelligence. 4. Lifecycle Management • Manage post-approval changes (variations), renewals, labelling updates, and compliance reporting. • Ensure timely implementation of changes across the region. • Maintain up-to-date regulatory documentation and databases. 5. Compliance & Intelligence • Monitor and interpret regional regulatory guidelines, regulations, and policies relevant to biosimilars. • Provide periodic update on impact and compliance to regulatory head. • Support regulatory inspections as needed. 6. Cross-functional Collaboration • Work with QA, QC, SCM, PM, Clinical, Commercial, and BD teams to align regulatory priorities. • Support business development activities, due diligence, and partnership evaluations for the region. Qualifications & Experience: • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field; Regulatory certification is a plus. • 12-15 years of experience in regulatory affairs in the pharmaceutical/biotech industry, at least 5 years’ experience in biosimilars is preferred. • Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity requirements) and ICH guidelines. • Experience with regulatory submissions in MENA and CIS countries is mandatory. • Familiarity with SFDA, EMA reliance procedures, and dossier localization requirements. Required Skills & Competencies: • Strong project management and organizational skills. • Excellent written and verbal communication skills. • Strategic thinking with attention to detail. • Proactive, collaborative, and culturally aware. • Ability to manage multiple priorities in a fast-paced environment
-
Regulatory Affairs Specialist
4 days ago
bangalore, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
-
Regulatory Affairs Manager I
3 weeks ago
Bangalore, Karnataka, India AstraZeneca Full timeJob Title Regulatory Affairs Manager I Global Career Level D1 Introduction to role Are you ready to be part of a team that transforms drug development strategies into reality The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning coordination and execution of assigned...
-
Regulatory Affairs Manager
21 hours ago
bangalore, India Biocon Biologics Full timeKey Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation...
-
Senior Manager Regulatory Affairs
2 days ago
bangalore, India One of the Leading Surgical solutions and Medtech Company Full timeOur client is one one of the pioneers and trusted surgical solutions and medtech companies. They export to more than 80 countries worldwide and collaborate with hospitals, governments, and healthcare systems worldwide to strengthen surgical ecosystems and improve patient lives.Primary Role: The QA & Regulatory Affairs Manager leads and oversees all...
-
Senior Manager Regulatory Affairs
19 hours ago
Bangalore, India One of the Leading Surgical solutions and Medtech Company Full timeOur client is one one of the pioneers and trusted surgical solutions and medtech companies. They export to more than 80 countries worldwide and collaborate with hospitals, governments, and healthcare systems worldwide to strengthen surgical ecosystems and improve patient lives. Primary Role: The QA & Regulatory Affairs Manager leads and oversees all...
-
Regulatory Affairs Manager- SME
4 days ago
bangalore, India Mount Talent Consulting Pvt Ltd. Full timeDomain lead - SME - Safety and Regulatory - BA offshoreExpert in Pharma domain’s multiple functions especially Regulatory and SafetyWell versed with business functions and tools used by industryAble to create integrated solutions and able to address customer pain pointsAble to draw process flowsAct as Technical Product Owner for global regulatory systems...
-
Regulatory Affairs Manager- SME
3 days ago
Bangalore, India Mount Talent Consulting Pvt Ltd. Full timeDomain lead - SME - Safety and Regulatory - BA offshore Expert in Pharma domain’s multiple functions especially Regulatory and Safety Well versed with business functions and tools used by industry Able to create integrated solutions and able to address customer pain points Able to draw process flows Act as Technical Product Owner for global regulatory...
-
Regulatory Affairs Specialist
4 days ago
bangalore, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
-
Regulatory Affairs Executive
2 weeks ago
Bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
-
Regulatory Affairs Executive
2 weeks ago
bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
