Regulatory Associate Manager - Product Variations, CD CMC

GSK India

6 - 10 years

14 - 18 Lacs

bengaluru

Posted:1 hour ago| Platform:

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Skills Required

procurement supply chain career development pharma pharmacy focus clinical development oncology contract manufacturing recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

ResponsibilitiesThis role will provide YOU the opportunity to lead key activities to progress YOUR career
These responsibilities include some of the following:- Manage regulatory activities for product variations from planning to submission and approval
- Prepare, review and approve CMC components of regulatory dossiers for global submissions
- Assess data and documentation to confirm they are complete, compliant and fit for purpose
- Identify regulatory risks and raise clear, timely escalations with mitigation options
- Work closely with supply chain, quality, clinical and external manufacturers to gather and align submission data
- Share knowledge, coach colleagues and contribute to improving regulatory processes and tools
Why YouThis role is on-site in India with opportunities to collaborate with global teams
We welcome applicants from diverse backgrounds
You will join a supportive, high-impact team that values learning and career development
If you want to grow your expertise in regulatory CMC and contribute to meaningful work for patients, we encourage you to apply
Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals:- Bachelor s degree in chemistry, pharmacy, pharmaceutical sciences or a related science/technical field
- Minimum 5 years of regulatory affairs experience with a focus on CMC and product variations
- Experience preparing or managing CMC dossiers for regulatory submissions
- Knowledge of global regulatory guidelines and expectations for CMC content
- Strong organisational skills and experience managing multiple projects and deadlines
- Good written and verbal communication skills in English for clear, concise dossier writing and stakeholder engagement
Preferred QualificationIf you have the following characteristics, it would be a plus:- 6 to 10 years experience in pharmaceutical regulatory CMC, including global submissions
- Prior experience working with contract manufacturing organisations and supply chain partners
- Experience acting as dossier reviewer or approver
- Ability to interpret and advise on regional regulatory requirements
- Experience mentoring or training junior staff and building capability
- Comfortable working in a matrix environment with cross-functional teams
How to applyWe want to hear from you
If this role fits your experience and ambitions, please apply now
Include your CV and a short note about why you want to join our team

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