Regional Regulatory Affairs SpecialistBiocon Biologics • Bengaluru, Republic Of India, IN
Regional Regulatory Affairs Specialist
Biocon Biologics • Bengaluru, Republic Of India, IN
22 days ago
Job descriptionOversee 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. 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. 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. Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field; 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. 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
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
3. Agency Engagement & Partner Coordination
5. Compliance & Intelligence
Qualifications & Experience :
Regulatory certification is a plus.
Required Skills & Competencies :
Create a job alert for this search
Regulatory Specialist • Bengaluru, Republic Of India, IN
Related jobs
)
Author and compile Regional / Country PI as per regulatory authority labelling requirements and GSK process and standards.
Author and compile market-specific supporting documentation for labelling sub...Show more
Coordination of CTA submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with Organization policy and pro...Show more
Regulatory Affairs Specialist – (APAC & RoW)
vueverse. • Bengaluru, IN
Regulatory Submissions & Compliance.Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, ...Show more
Last updated: 23 days ago • Promoted
Regulatory Affairs Specialist I (Admin)
Thermo Fisher Scientific • Bengaluru, Karnataka, India
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly...Show more
Last updated: 7 days ago • Promoted
Global Regulatory Affairs Publisher
Biocon Biologics • Bengaluru, Republic Of India, IN
We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team.In this role, you will be responsible for preparing and submitting high-quality el...Show more
Last updated: 25 days ago • Promoted
Regulatory Affairs Manager
Biocon Biologics • Bengaluru, Karnataka, India
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 alignmen...Show more
Last updated: 22 days ago • Promoted
Clinical Research Regulatory Coordinator
Stryde Research • Bengaluru, IN
We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and New Jersey.
M+ patients through 100+ specialized clinics with d...Show more
Last updated: 1 day ago • Promoted
Regulatory Affairs Lead
Biocon Biologics • Bengaluru, Republic Of India, IN
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 alignmen...Show more
Last updated: 30+ days ago • Promoted
Regulatory Affairs and Compliance Advisor
Manipal Hospitals (MHEPL) • Bengaluru, Republic Of India, IN
KEY PURPOSE OF THE JOB (Position Summary) : .Manage day to day activities as required by the Legal Team;.Maintain, monitor and analyzes statutory and regulatory compliance levels across all group hos...Show more
Last updated: 16 days ago • Promoted
Regulatory Finance Specialist
Ola Electric • Bengaluru, Republic Of India, IN
Managing end-to-end government Production Linked Incentive (PLI) schemes and related compliances.Preparing PLI - Domestic Value Addition (DVA) applications for certification by the Ministry and its...Show more
Last updated: 10 days ago • Promoted
RCFCR Phoenix Lead
Standard Chartered Bank • Bengaluru, Karnataka, India
This job is with Standard Chartered Bank, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly....Show more
Last updated: 19 days ago • Promoted
Regulatory Specialist III, Country Labelling
ScaleneWorks • Bengaluru, karnataka, India
Quick Apply
Last updated: 30+ days ago
Business Analyst - Regulatory Affairs
Alp Consulting Ltd. • Bengaluru, Republic Of India, IN
A Business Impact Analyst is responsible for assessing the impact of potential risks, threats, and vulnerabilities to a company's ongoing operations, regulatory compliance, corporate reputation, an...Show more
Last updated: 3 hours ago • Promoted • New!
Regulatory Affairs Specialist
Zepto • Bengaluru, Republic Of India, IN
Responsible for ensuring end-to-end statutory and labour law compliance for all Zepto entities and store locations across India.
The role covers Provident Fund, ESI, Professional Tax, LWF, Shops & E...Show more
Last updated: 4 days ago • Promoted
ECTD Submission Specialist
Biocon Biologics • Bengaluru, Republic Of India, IN
We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team.In this role, you will be responsible for preparing and submitting high-quality el...Show more
Last updated: 25 days ago • Promoted
Principal Reg Affairs Assistant
Thermo Fisher Scientific • Bengaluru, Karnataka, India
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly...Show more
Last updated: 3 days ago • Promoted
CTA / IND Regulatory Specialist
ScaleneWorks • Bengaluru, Karnataka, India
Quick Apply
Last updated: 30+ days ago
Publishing Specialist
Biocon Biologics • Bengaluru, Karnataka, India
Strong understanding of eCTD, NeeS, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as : Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe A...Show more
Last updated: 30+ days ago • Promoted
Regulatory Publishing Expert
Biocon Biologics • Bengaluru, Republic Of India, IN
We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team.In this role, you will be responsible for preparing and submitting high-quality el...Show more
Last updated: 25 days ago • Promoted
Biosimilar Regulatory Strategist
Biocon Biologics • Bengaluru, Republic Of India, IN
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 alignmen...Show more
Last updated: 22 days ago • Promoted