Job Title: Senior Specialist – Regulatory Project Management
Job Id: 287385
Location: Electronic City Phase 1, Bangalore, Karnataka, India
Job Type: Full-time
Job Description
At our organization, we dream big and are passionate about caring for people, customers, patients, and the planet. We are always looking for curious minds to innovate with us and explore new possibilities. Join us to break barriers and discover more in the fields of Healthcare, Life Science, and Electronics.
Key Accountabilities:
Create project plans for significant regulatory submissions, including CTA/IND, MAA/NDA/BLA, and health authority meetings/scientific advice, ensuring plans are simplified to fit the complexity of each submission.
Collaborate closely with the Global Regulatory Lead/Regulatory Affairs Manager on submission strategies and with the Submission Manager for execution.
Handover planned submissions to GRA Operations for smooth execution, ensuring all relevant information is provided for submission initiation.
Orchestrate the execution of submissions to Health Authorities.
Manage crisis situations that could impact project timelines and provide intervention where necessary.
Set up risk registers for GRST and STF, and maintain GRA-owned risks in the iMAP system.
Guide regulatory activities across functional areas, harmonizing efforts within teams.
Lead the Submission Taskforce for initial applications and additional planned submissions.
Oversee the setup of hyper care for important submissions to Health Authorities.
Track budget demand and actuals for GRA&RDQ and liaise with Global Project Management and Project Controllers.
Conduct scenario planning to assess global regulatory resource and budget demand for various projects.
Manage post-deal activities such as operational aspects of asset transfer and develop plans for internal activities post-licensing.
Maintain and improve tools and templates for project management to ensure compliance with Health Authority requirements.
Establish strong collaborations with the project controller and global project management teams.
Contribute to the development of regulatory tools and templates, ensuring they meet health authority requirements.
Required Skills & Competencies:
Regulatory Affairs Knowledge: Thorough understanding of regulatory dossier types, post-approval changes, and global regulatory requirements for pharmaceutical products.
Collaboration Skills: Ability to work effectively in teams, manage cross-functional communication, and influence team spirit positively.
Project Management: Proficient in portfolio and project management practices.
Communication: Excellent written and spoken communication skills, particularly in English.
Detail-Oriented: Ability to ensure the required quality in projects without losing sight of broader objectives.
Customer Orientation: Strong focus on meeting customer needs and providing excellent service.
Education & Experience:
Education: Degree in Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent; PhD preferred).
Experience: 8–14 years of relevant experience in a pharmaceutical environment, regulatory affairs, or related academia/R&D fields. At least 6-8 years of experience in regulatory affairs or regulatory project management.
Training: Advanced training in portfolio & project management related disciplines is an advantage.
Financial Dimensions:
Support the update of the iMAP system for the quarterly direct cost planning and consolidate cost demand against actual spending.
Who You Are:
Diversity and Inclusion: We value workforce diversity and are committed to providing equal opportunities in employment regardless of race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, or gender identity.
Growth Opportunities: We believe in creating access to opportunities for all employees to develop and grow at their own pace.
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