Senior Software Engineer-SDS Author/Regulatory DocumentationSpecialist - Bengaluru

We are seeking highly skilled and experienced Life Sciences Regulatory Affairs (RA) Team Leader to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring and/or other assigned RA activities. This leadership role oversees a team of regu ...

Around 4-6 years of experience in handling life cycle management of approved drug products in various markets. · Contribute to preparation and delivery of regulatory maintenance submissions from a global and/or regional perspective. · Liaise closely with cross-functional members ...

A regulatory affairs consultant with around 7-10 years of experience in handling life cycle management of drug products. · ...

We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. · Preparing high-quality documentation required for regulatory submissions of drugs, biologics, medical devices, · or combination products. ...

Acting as the in-house regulatory authority translating global guidelines into product requirements and AI workflows. Shaping and validating systems that support end-to-end global regulatory submissions. · ...

We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Team Leader to join our LS Practice team. · ...

Around 4-6 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets. · ...

The Regulatory Affairs Specialist will develop regulatory strategies, collaborate with global teams, and maintain awareness of country-specific regulations. · Developing regulatory strategy including filling readiness of NDAs sNDA. · Responsible for ongoing renewals, variations a ...

The 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 and providing guidance to the cross functional and Area regulatory ...

Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products. · ...

We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. · The successful candidate will be responsible for LS Regulatory Authoring and/or other assigned RA activities.The role will involve knowle ...

The job holder is responsible for managing end-to-end regulatory lifecycle submissions across multiple markets, ensuring timely delivery and compliance with regulatory authority requirements, guidance and GSK processes. · ...

+We are looking for a Compliance Specialist - Global Market Access to act as the single point of contact for strategic global customer account. This is high ownership and visibility role that sits at intersection of regulatory compliance program management & customer engagement. ...

You will lead regulatory projects for Vaccines portfolio that support product lifecycle activities across markets. · ...

We are looking for an experienced Manager – Industrial Licensing · to manage end-to-end industrial licensing, statutory approvals, · and regulatory compliance across business units. · The role involves close coordination with government authorities · and internal stakeholders to ...

Write regulatory documents supporting global filings (CTD Module 2 and Module 5) for clients across different therapy areas. · Author clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs. · ...

Syner-G BioPharma Group seeks a Manager/Senior Manager of Regulatory Affairs to provide regulatory consulting to a large, global pharmaceutical Client in the areas of Chemistry, Manufacturing, and Controls (CMC), to ensure compliance with FDA, EMA, and global regulatory requireme ...

Syner-G seeks a Manager/Senior Manager of Regulatory Affairs to provide regulatory consulting to a large global pharmaceutical client in the areas of Chemistry Manufacturing and Controls ...

This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. · ...

Build and maintain mutually beneficial relationships among Government agencies or organizations. · ...