Regulatory Affairs Manager

7 days ago

Bengaluru, India Biocon Biologics Full time

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 Manager

    3 days ago

    Bengaluru, Karnataka, India Kumar Organic Products Full time

    Job Title: Regulatory Affairs ManagerDepartment: Regulatory Affairs / Quality & ComplianceReporting to: Head Regulatory AffairsJob Purpose:To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing...

  • Manager - Regulatory Affairs

    3 weeks ago

    Bengaluru, India Aarna Hr Solutions Full time

    Job Description We are seeking a highly experienced and meticulous Manager - Regulatory Affairs to oversee and execute all regulatory activities for drug substances and products. The ideal candidate will be responsible for the preparation, submission, and management of various regulatory documents, ensuring compliance with global regulatory agencies. This...

  • regulatory affairs

    7 days ago

    Bengaluru, Karnataka, India Randstad MENA Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Job Description Job Details This job offer closes 6 January 2026.SummaryLocation: Bengaluru, Karnataka Company: A client of Randstad India Type: Temporary Posted on: 7 November 2025 Reference Number: JPC Next StepsContact the recruiter Set a job alert Create an account Search jobs Randstad Professional We bring diverse and...

  • Regulatory Affairs

    6 days ago

    Bengaluru, Karnataka, India MM Staffing & Career Consultants Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description:Job SummaryThe Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all...

  • Manager - Regulatory Affairs

    1 week ago

    Bengaluru, Karnataka, India Aarna HR Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company Description Greeting Aarna HR Solutions is a Human Resource Recruitment Company providing services to Various IT, ITES and Non- IT companies across India. Aarna Solutions strive towards hiring the best and the brightest talent in the industry. We hire individuals with a strong sense of pride in their performance, team spirit, and a desire to excel. ...

  • Regulatory Affairs Manager I

    3 weeks ago

    Bengaluru, India AstraZeneca Full time

    Job Description Job 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...

  • Regulatory Affairs Executive

    1 week ago

    Bengaluru, Karnataka, India Kerala Ayurveda Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Are you passionate about ensuring regulatory excellence in the world of Ayurveda and nutraceuticals?Kerala Ayurveda Limited is looking for a Regulatory Affairs Executive with 4-6 years of experience to join our growing team in Bangalore. This is a great opportunity to work at the intersection of traditional Ayurvedic wisdom and global compliance standards,...

  • regulatory affairs

    1 week ago

    bengaluru, India Randstad Full time

     What do we offer you? Competitive salary and benefits packageRemote work opportunitiesProfessional development and growth opportunitiesCollaborative and supportive team environmentChance to make a significant impact on a global scaleWork-life balance Who are you?We are looking for a dedicated and experienced Regulatory Affairs Specialist to join our...

  • Regulatory Affairs

    1 week ago

    Bengaluru, Karnataka, India Dozee Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Note- Candidates who can join immediately can apply Job Description -Regulatory Affairs- Intern Overview We are seeking a highly motivated and experienced person to join our team Responsibilities:Participate in the development of regulatory submission and approval strategy in multiple countries.Maintain awareness and understanding of new and existing...

  • Regulatory Affairs Manager

    7 days ago

    Bengaluru, India Whatjobs IN C2 Full time

    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...