Senior Specialist Regulatory Project Management Office

Work Your Magic with us! 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

Your Role:

The Regulatory Project Manager Officer will be a member of the GRA Portfolio Management Team to contribute to defining the annual strategic direct to evolve the impact of the function for the GRSTs / IRSTs and GRA functions (timelines, risks, priorities, direct costs, and FTE demand)

The position will be working in a matrix organization with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to enable the preparedness of the employees to work on different projects and roles, to facilitate communication within the matrix organization, to ensure efficient and scalable resourcing supporting the business priorities.

Who You Are:

Experience: 8–14 years of work experience in a pharmaceutical environment, competent authority, or academia/R&D experience related to the role. 

Minimum 6-8 years of regulatory affairs or regulatory project management office experience.

Education:

Degree in a Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent degree); higher degree preferable (e.g., PhD in a scientific discipline).

Advanced training in portfolio & project management experience-related disciplines will be a strong advantage.

Job Specific Competencies & Skills:

Key Accountabilities
•    Act as PMO for GRSTs and create, maintain, and evolve templates and tools used in the GRSTs.
•    Close collaboration with RPMs and GRLs to ensure that templates and tools are appreciated in the GRSTs along the lifecycle of assets and allow quick access to relevant information in a harmonized fashion across the GRSTs.
•    Consolidate GRST relevant information at portfolio level on a quarterly basis (GRA Healthcheck)
•    Collaborate with Leaders in TA Onc and TA Finer to steer, review and evolve metrics and KPIs measured in the GRA Healthcheck to provide transparent overview.
•    Generate insights from data and reports to provide recommendation for improvements and enable a learning organization.
•    Perform the annual GRST survey to get insights on the perception of all Global Regulatory Strategy Team members on the impact and provide insights to GRSTs as well as leaders across the TAs, functions, and regions.
•    Close collaboration with SPH and RQS Operations to define business questions and requirements for reports and analyses to allow generation of GRA insights. Be the iMAP steward for the GRA functions.
•    Be a member of the RQS SME group for FTE demand forecasting. 
•    Close collaboration with the Strategic Sourcing and Planning team within RQS Operations
•    Coordinate the FTE demand planning SME group for GRA functions (TA Onc, TA Finer, REG CMC, REG Intl., Labeling and GRASP).
•    Orchestrate the monthly update of skill assignments in the HR system for GRA functions and perform needed updates for TA FINER and TA Onc.
•    Collaborate with GRA functions to generate needed insights on scenarios having resource implications for the functions and skills.

• Requires in-depth knowledge and experience in own discipline and beyond to supplement formal knowledge in order to apply principles and concepts to own discipline in resolving issues as they arrive.
•    Thorough understanding of the Regulatory, R&D, including process and technology solutions
•    Knowledge in business administration is a plus
•    Portfolio & Project Management experience

Financial Dimension
•    Supports the RPMs to update the iMAP system for the quarterly direct cost planning exercise and allows consolidation of direct cost demand, allowing comparison with actual spending assigned to the GRA part of the PST budget.

Job Location:

Electronic City Phase 1: Bangalore

We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day, which is why equality and inclusion are at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis, including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!