Associate Director/ Senior Manager Regulatory Excellence Center

Job Description

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.Job Title - Senior Manager Regulatory Excellence CenterJob Location- Electronic City Phase 1 - BangaloreYour Role:The Senior Manager Regulatory Excellence Center establish, develop and lead highly efficient team within the Regulatory Excellence Center, by executing full end to end people and performance management activities, facilitating the operational execution within the matrix organization, providing guidance to the employees and monitoring quality standards and objectives adherence.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.People responsibilities: Full end to end people and performance management responsibility for a middle size teamWho You Are:Experience: Minimum 13 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 5 years of people management 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 Business related discipline will be a strong advantageJob Specific Competencies & Skills:People management and Leadership

• Ability to interpret and apply in practice key leadership and people management approaches
• Ability to take decisions in line with the set authority, and to support and guide the team in the decision-making process
• Budget planning and management
• Ability to build strong and efficient teams, with equal focus on productivity, compliance and collaboration
• Ability to cascade, interpret and communicate the high-level company and departmental objectives into team and individual day-to-day tasks
• Dedication to the team excellence and constant development, along with the own one
• Strong project management and documentation skills, proactive communication approach Maintain appropriate risk assessment and mitigation in cooperation with line manager /team lead
• Ability to work within a matrix organisation, build relationships with internal or external stakeholder

Regulatory and Pharma:

• Experiences in drug development and marketing authorization applications and maintenance activities in Europe (e.g. variations, work-sharing, PSUSA procedures) as well as for global markets
• In Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc.) and LCM strategies
• In depth knowledge of regulations and prior experience in at least 2 other major markets
• Substantial direct experience of working in Global Regulatory Affairs and leading delivery of regulatory projects through key milestones and investment decisions
• Ability to keep self and the team updated and aligned with the changing regulatory requirements; where applicable, to support the team in regulations interpretation
• Advanced level of experience with several different RA applications (RIM, EDMS, Publishing tools)
• Excellent written and spoken English language

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!Curious Apply and find more information at https://jobs.vibrantm.com,

Keyskills :
project managementfinancedrug developmentcompliancespoken englishpeople managementreportingcustomer relationsrisk assessmentquality standardsenvironmental impact assessmentadvisory