Emerging Markets Regulatory Specialist
1 week ago
We seek an experienced Regulatory Affairs professional with a strong background in biologics/biosimilars registration across Emerging Markets, including the Middle East, Asia, LATAM, Africa, and CIS regions.
Key Responsibilities:
- Prepare and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets.
- Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa.
- Support product registrations, renewals & variations.
The ideal candidate will have hands-on experience working with local affiliates or partner companies in Emerging Markets.
Required Skills and Qualifications:
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or related field.
- Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets.
- Knowledge of CTD structure, Module 1 customization, and regional submission formats.
Awarding
We offer a competitive compensation package and opportunities for career growth and development.
Additional Information:
- Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines.
- Experience working with electronic submission platforms.
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Biocon Biologics Full timePosition SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Biocon Biologics Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India Biocon Biologics Full timePosition Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations...
-
Regulatory Affairs Specialist
5 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timePosition Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
-
Biosimilar Product Regulatory Specialist
2 weeks ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,80,00,000**Regulatory Affairs Specialist: Emerging Markets Role**We are seeking a skilled Regulatory Affairs Specialist to join our team in managing regulatory activities for biosimilar products in the emerging market, with a strong focus on LATAM region.This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and...
-
Senior Regulatory Compliance Specialist
1 day ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 50,00,000**Job Title:** Senior Regulatory ManagerAs a seasoned professional in the field of Regulatory Affairs, we are seeking an individual with extensive experience in biologics/biosimilars registration across Emerging Markets. This role is responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with...
-
LATAM Biosimilar Regulatory Strategist
2 weeks ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000**Job Title:** Regulatory Affairs SpecialistJob Description:We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for managing regulatory activities for biosimilar products in the emerging market, with a strong focus on LATAM region.Key Activities required for this role...
-
Bioequivalence Regulatory Affairs Expert
6 days ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 25,00,000 - ₹ 40,00,000Job OpportunityWe are seeking a skilled Regulatory Affairs Professional to manage regulatory activities for biosimilar products in the emerging LATAM market.This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations.Main Responsibilities:Develop and...
-
Emerging Markets
5 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timeOVERALL, JOB RESPONSIBILITIES:Own the Servicing of orders for regional Sales Teams in the defined customer service framework for timely issue resolutionValidate demand over the horizon, assigns prioritization to demand/orders/customersValidates the demand with POs available, LCs required, Regulatory clearances, Artwork Details, SKU codes, IL Check, Mfg...
-
Senior Regulatory Manager
1 week ago
Bengaluru, Karnataka, India Biocon Biologics Full timeWe are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates,...
