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Post : Regulatory Project Manager
Job Description
Your Role
The Regulatory Project Manager is responsible for global regulatory planning and tracking of regulatory deliverables for moderate-to-highly complex submissions to health authorities worldwide (including submission planning). Managing operational aspects of products (assets) with moderate to higher life cycle maintenance activities.
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.
Key Accountabilities
• Creates project plan for initial CTA/IND, MAA/NDA/BLA and significant regulatory submissions (HA meetings/Scientific Advice). Simplified plans are to be in place considering the complexity of the submission.
• Works closely with the Global Regulatory Lead/Regulatory Affairs Manager providing the submission strategy and with the Submission Manager executing the submissions.
• Responsible for the handover of planned submissions to GRA Operations to ensure smooth execution. All relevant information to initiate the planning and execution of concrete submission(s) provided to Submission Manager (incl. “event” creation in Breeze)
• Accountable for orchestrating the execution of Submissions to Health Authorities
• Crisis management and intervention in case of issues that impact project timelines
• Setup the risk registers for GRST and STF. Setup and maintain GRA-owned risks in iMAP system.
• Manages regulatory activities by guiding teams and harmonizing across functional area.
• Drive the Submission Taskforce to ensure appropriate submission package, show interdependencies of deliverables and address risk and issues.
• Accountable for the leadership and day-to-day operation of the Submission Task Force for initial applications (IND, CTA, MAA/BLA/NDA) and if needed for additional planned submission.
• Ensures the set-up of hyper care for important submissions to Health Authorities
• Consolidates budget demand and tracking of actuals for GRA&RDQ and be key contact for Global Project Management and Project Controller: Ensure PO is setup for any costs which will be booked at the project budget (e.g. consultants, HA fees)
• Scenario planning: assessing global regulatory resource and budget demand for rollout/due diligence projects.
• Key contact after deal closure of new in licensing opportunities or out-licensing to orchestrate the operational aspects of asset transfer and develop with the GRL the plan to initiate internal activities considering deal agreement.
• Manages and improves tools and templates for project management, ensuring compliance with Health Authority requirements.
• Establish and maintain strong collaboration with the project controller and global project management.
• Good knowledge about regulatory affairs and specifically post approval changes, regulatory dossier types, and main regulatory procedures globally. Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA's, etc.) as well as the legalization framework.
• Thorough knowledge of EU & international regulatory requirements pertaining to the life cycle management of authorized products.
• Contributor level experience with RIM and EDMS RA applications.
• Excellent written and spoken communication skills and English language knowledge.
• Outstanding ability to work in teams and positively influence team spirit.
• Ability to work diligently to ensure required quality without losing sight of the big picture.
• Excellent result orientation and willingness to take ownership.
• Strong customer orientation.
Candidate Profile
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.
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 manager experience.
Additional Information
Experience : 5+ Years
Qualification : Degree in a Life Science, Medical, PharmD
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th October 2024
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