Senior Specialist – Regulatory Project Management
Job Id: 287385
Location: Electronic City Phase 1, Bangalore, Karnataka, India
Job Type: Full-time
About the Role
As a Senior Specialist – Regulatory Project Management, you will be responsible for creating and managing regulatory project plans, leading the submission process, and ensuring smooth execution. You will work closely with the Global Regulatory Lead and Submission Manager to manage and track submission milestones, addressing issues and risks that may impact timelines. Your key responsibilities will include:
Creating project plans for regulatory submissions (CTA/IND, MAA/NDA/BLA).
Collaborating with the Submission Manager for the execution of the submissions.
Managing regulatory activities across functional teams and driving the Submission Taskforce.
Orchestrating the execution of submissions to Health Authorities and managing risks.
Consolidating budget demand and tracking actuals for GRA&RDQ.
Scenario planning for regulatory resource and budget demand for projects.
Managing tools and templates for project management to ensure compliance with Health Authority requirements.
Establishing collaboration with the project controller and global project management teams.
Who You Are
Experience: 8–14 years in a pharmaceutical environment, competent authority, or academia/R&D.
Minimum 6–8 years of regulatory affairs or regulatory project management experience.
Advanced training in portfolio & project management is a strong advantage.
Education: Degree in Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent degree); higher degree (PhD) preferred.
Strong knowledge of regulatory affairs, post-approval changes, and regulatory dossier types.
Familiarity with EU & international regulatory requirements for product lifecycle management.
Contributor level experience with RIM and EDMS RA applications.
Excellent written and spoken communication skills in English.
Strong team player with excellent customer orientation and result-driven mindset.
What We Offer
We value diversity and inclusion, and we are committed to providing equal opportunities for all to grow and develop. Join us and become part of a team that fosters innovation and strives for excellence in science and technology.
Apply now and become a part of our diverse team!
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