CMC & Medical Device Consultant - Regulatory Affairs
G&L is excited to be expanding our Regulatory Medical Devices team in our Indian office locations.
We are seeking experienced CMC and Medical Devices Regulatory Affairs consultants to support a diverse range of clients across the pharmaceutical, biotechnology, and medical device sectors. This role will involve contributing to development projects, lifecycle management, and compliance initiatives for both small and large molecules, biologics, and combination products.
Your role will provide strategic and operational regulatory support, ensuring compliance with global regulatory requirements, particularly in the EU and US markets. Experience with Combination Products is preferred, making previous knowledge in biopharmaceuticals highly desirable.
This role will commence in Quarter Two, 2025.
The Role
The role of a consultant at G&L is varied, and no project is the same. This role’s key responsibilities may include:
Regulatory strategy and development
- Providing expert guidance on CMC and medical device regulatory strategies for development projects.
- Advising G&L’s clients on regulatory requirements for combination products, biologics, and pharmaceuticals across global markets.
- Developing and executing a regulatory roadmap for product approval, lifecycle management, and post-market compliance.
Regulatory submissions and documentation
- Preparing, reviewing, and submitting CMC sections of regulatory filings (INDs, IMPDs, BLAs, NDAs, MAAs, CTAs, 510(k)s, PMAs, and technical files).
- Supporting the preparation and submission of post-approval variations, renewals, and annual reports.
- Ensuring regulatory submissions comply with FDA, EMA, and other global agency requirements.
Lifecycle management and compliance
- Managing regulatory activities related to product maintenance, manufacturing changes, labeling updates, and risk management.
- Supporting clients in gap assessments, due diligence, and regulatory compliance audits.
- Monitoring changes in regulatory frameworks and advising clients on impact and necessary actions.
Cross-functional collaboration
- All G&L consultants are expected to have excellent communication skills, both written and verbal. You should have a natural aptitude for diplomacy and persuasion. You should have confidence when speaking to global stakeholders, both junior and senior.
- You will be working closely with a variety of stakeholders – both internal and external. G&L project teams are often global, so flexibility with time zones is appreciated.
- Working closely with G&L’s client stakeholders, including R&D, Quality, Manufacturing, and Clinical teams to align regulatory strategies with business objectives.
- Potentially acting as a regulatory liaison in interactions with health authorities and notified bodies.
Requirements
- A degree in a Life Sciences field is essential. Advanced degree preferred.
- A minimum of 5-10 years of regulatory affairs experience in CMC and medical devices.
- Strong experience with combination products, biologics, and pharmaceuticals.
- Proven working knowledge of ICH guidelines, FDA regulations, EMA guidelines, ISO 13485, MDR (EU), and GMP requirements.
- Hands-on experience with regulatory submissions, lifecycle management, and post-market compliance.
How to Apply
If you would like to hear more, please send your details to: talent@gandlscientific.com today!
G&L is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.
