Info Tech Project Manager_Regulatory Affairs

2 months ago

bangalore, India Biocon Biologics Full time

At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases.

We have 6500 people across the world innovating, creating, and delivering quality healthcare collaboratively, while employing the highest levels of ethics and integrity, every day.

We have been listed in the Top 10 Bio-Pharma Companies to Work For more than once by Science Magazine, including this year.


KEY RESPONSIBILITIES

The incumbent will work closely with the team under the supervision of the Digital Business Partner, leading key technology and digital projects and ensuring successful rollouts.

More specifically s/he will lead the following responsibilities:

  • Define project scope, objectives, and deliverables. Develop a detailed project plan, including timelines, resources, and budget.
  • Lead and coordinate cross-functional teams to ensure project goals are met. Assign tasks and responsibilities to team members.
  • Maintain open communication with all project stakeholders, including Regulatory Affair / staff, management, and other relevant departments.
  • Identify potential project risks and develop mitigation strategies. Proactively manage issues that may arise during the project.
  • Allocate and manage project resources, including personnel, budget, and technology, to ensure project success.
  • Oversee the execution of IT Systems for Regulatory Affairs ensuring they are completed on time, within scope, and within budget.
  • Collect and analyse data related to IT systems to measure their effectiveness and make data-driven decisions.
  • Prepare and present regular project status reports to Regulatory Affairs leadership and other stakeholders.
  • Identify opportunities for process improvement within Regulatory Affairs and implement best practices.
  • Maintain thorough project documentation, including project plans, status reports, and project closure documents.


YEAR ONE CRITICAL SUCCESS FACTORS

  • Successfully complete IT systems implementations within time, cost and quality standards, in line with business expectations


PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Bachelors in Engineering or Masters degree in a related discipline, including a minimum of 8 to 12 years of experience gained in technology implementation in the regulatory affairs space
  • Experience in execution of Small , Medium and large size projects.
  • Experience in working in an on-site & off-shore model, handling stakeholders from various locations
  • Excellent oral/ written communication skills
  • Self-starter, with the ability to work and execute independently with minimal oversight.


Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.

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