Senior Specialist Regulatory Project Management Office

8-14 years

Not Disclosed

Bangalore

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: MSc./M. Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Project Manager Officer

Location: Electronic City Phase 1, Bangalore

About the Company:

At our company, we are dedicated to breaking barriers, exploring new possibilities, and discovering more. Our colleagues across the globe are passionate about innovating with science and technology to enrich people’s lives in healthcare, life science, and electronics. We dream big and care deeply for our diverse mix of people, customers, patients, and the planet. We are constantly on the lookout for curious minds ready to imagine the unimaginable with us.

Your Role:

As a Regulatory Project Manager Officer, you will be an integral part of the Global Regulatory Affairs (GRA) Portfolio Management Team. Your primary responsibility will be to contribute to the strategic evolution of the function by managing timelines, risks, priorities, direct costs, and FTE demand for the GRSTs/IRSTs. You will work in a matrix organization, collaborating with various stakeholders to ensure resource efficiency and alignment with business priorities.

Key Responsibilities:

Project Management Office (PMO): Act as PMO for GRSTs, creating and evolving templates and tools that support the lifecycle of assets and ensure quick access to relevant, harmonized information.
Collaboration & Communication: Work closely with Regulatory Project Managers (RPMs) and Global Regulatory Leads (GRLs) to ensure that tools and templates are efficiently utilized across the GRSTs, facilitating a streamlined process.
Data & Reporting: Consolidate GRST relevant data on a quarterly basis, generating insights from reports to identify areas for improvement and contribute to a learning organization.
FTE Demand Planning: Be part of the FTE demand forecasting SME group and collaborate with various teams to generate insights and forecasts related to resource needs.
Healthcheck & KPIs: Collaborate with leaders in Therapeutic Areas (TA) such as Oncology (Onc) and Finer, to review and evolve metrics, KPIs, and the GRA Healthcheck, providing transparency and actionable recommendations.
Surveys & Insights: Conduct the annual GRST survey to assess team perception and provide feedback to improve overall team performance.
Collaboration with RQS Operations: Work closely with RQS operations and the Strategic Sourcing and Planning team to define reporting requirements and generate GRA insights.
System Stewardship: Act as the iMAP steward for GRA functions, managing system updates and ensuring data integrity across various regulatory teams.

Who You Are:

Experience: 8-14 years of experience in a pharmaceutical environment, competent authority, or academia/R&D, with at least 6-8 years in regulatory affairs or regulatory project management.
Education: Degree in Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent degree); higher degree (e.g., PhD) preferred. Advanced training in portfolio & project management is a plus.
Skills:
- In-depth knowledge of regulatory, R&D processes, and technology solutions.
- Strong business administration knowledge is a plus.
- Proven experience in portfolio and project management.
- Excellent analytical skills and the ability to generate actionable insights from complex data.
- Ability to collaborate across functions and work in a matrix organization.
- Strong communication skills, both written and verbal.
- Ability to manage competing priorities and deliver high-quality results.

Financial Dimensions:

Support the RPMs to update the iMAP system for quarterly direct cost planning, consolidating demand and comparing actual spending against the GRA budget.

What We Offer:

We are committed to creating an inclusive culture where diversity is celebrated, and everyone can bring their best self to work. We believe that diversity drives excellence and innovation, helping us lead in science and technology. We are dedicated to offering opportunities for personal and professional growth, allowing you to develop at your own pace. Join us in building a culture of inclusion and belonging, and make an impact that empowers everyone to work their magic!

Apply Now:

Ready to explore, innovate, and grow with us? Apply today to join our diverse team and help shape the future of regulatory affairs!

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Senior Specialist Regulatory Project Management Office

Job Description

Job Title: Regulatory Project Manager Officer

About the Company:

Your Role:

Key Responsibilities:

Who You Are:

Financial Dimensions:

What We Offer:

Apply Now:

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