Regulatory Affairs Specialist-API

Position 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...

Lead Specialist, Regulatory Affairs Job Description SummaryIn this role you will be focused on obtaining and maintaining global third-party supplier documentation for Imaging Accessories& Supplies (A&S) products. Under the instruction from A&S Product RA ensuring documentation requirements are obtained in accordance with the supplier contract for initial...

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,...

Lead Specialist - Regulatory Affairs Location : Bangalore Experience : 8+ years- In this role you will be focused on obtaining and maintaining global third-party supplier documentation for Imaging Accessories & Supplies (A&S) products. - Under the instruction from A&S Product RA ensuring documentation requirements are obtained in accordance with the supplier...

Role - Team Lead - International Regulatory Affairs Location - Bangalore Industry - Pharmaceutical Required Experience :- 10-15 yearsEducation :- M.Pharma / M.ScMust have experience in IRA handling regulated or unregulated region and submissions, handling a team of 2 for submissionWill lead a team of atleast 10 people(Team Leading exp is mandatory)Good...

Role - Team Lead - International Regulatory Affairs Location - Bangalore Industry - Pharmaceutical Required Experience :- 10-15 years Education :- M.Pharma / M.Sc Must have experience in IRA handling regulated or unregulated region and submissions, handling a team of 2 for submission Will lead a team of atleast 10 people(Team Leading exp is mandatory) Good...

Job Description We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: Plan and manage development of high...

Primary Responsibilities:Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval.Responsible for writing CMC modules 2 & 3.Exposure to EU & CIS region in Regulatory filingsManage and coordinate product life cycle management.Ensure regulatory compliance with local...

Role Summary /Key Responsibilities - DMF compilation and submission to global markets - Handling post approval submission and CIP assessments - Submission of DMF amendment & response to Health Authority queries - Providing customer support - Evaluating change control assessment - Providing Regulatory input for New molecule development activities -...

JOB TITLE :Regulatory Affairs - Senior Executive - ROW markets (Philippines, Kenya, Ethiopia, Nigeria)WHY SHOULD YOU JOIN SURGEWAY BIOSCIENCES?As a fast-growing organization, we believe in practicing openness and giving opportunities to one and all, to experiment and exhibit their talent. We provide a structured way of growth. We provide in-house training...