Specialist – Regulatory Affairs
Job Id: 286151
Location: Electronic City, Bangalore, Karnataka, India
Job Type: Full-time
About the Role
As a Specialist – Regulatory Affairs, you will be responsible for preparing regulatory dossiers and executing actions that support product compliance and market licensing security. You will collaborate with cross-functional teams to manage regulatory requirements and work with stakeholders from various disciplines. This role will involve supporting complex tasks under the guidance of more experienced License Management personnel, ensuring all submissions meet both company and health authority standards.
Key Responsibilities
Prepare regulatory documentation and manage full international submissions (e.g., new product applications and large variations).
Support life-cycle management activities in regions such as Europe and the USA, with additional experience in international regions considered an asset.
Understand and manage regulatory dossier types, post-approval changes, and regulatory procedures globally.
Ensure all supportive documents for product registration and lifecycle management (e.g., CPPs, GMP certificates, etc.) are in compliance with the necessary regulations.
Interpret country-specific and international regulatory guidelines to generate submission-ready deliverables.
Proactively communicate any potential risks to timelines and ensure adherence to agreed deadlines.
Contribute to project management tasks and documentation, ensuring effective communication across teams.
Utilize RIM, Vault, and EDMS RA applications in a contributor-level capacity.
Who You Are
Experience: Minimum 5 years of work experience in a pharmaceutical environment, with at least 1 year of regulatory affairs experience.
Education: Degree in Life Science or related discipline (preferably MSc).
Skills:
Experience in managing regulatory documentation and submissions.
Knowledge of regulatory affairs, dossier types, and post-approval changes globally.
Ability to interpret regulatory guidelines and generate submission-ready deliverables.
Project management and proactive communication skills.
Experience with RIM, Vault, and EDMS RA applications.
Excellent written and spoken English.
What We Offer
We celebrate diversity and inclusion, creating access and opportunities for all to grow at their own pace. Join us to contribute to a culture of innovation and excellence in science and technology.
Apply now and become a part of our diverse team!
Gujarat :
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