Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
About the role
- Regional Regulatory Lead overseeing EUCAN regulatory strategy for pharmaceutical projects and products. Planning submissions, coordinating meetings, and collaborating with regulatory authorities.
Responsibilities
- Provide a robust regulatory strategy for assigned products and/or projects, including guidance on maintenance & development needs in the EUCAN region, pediatric development requirements and clinical trial applications.
- Plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the EUCAN region.
- Organize, schedule, and carry out official in-person and remote meetings with regulatory authorities in EUCAN countries.
- Contribute as an active member to the Regulatory Excellence Team meetings and other meetings as required, to support development of worldwide regulatory strategies.
- Act as an interface & contact partner for RA functions in ROPUs and OPUs in EUCAN, Global RA and other cross-functional stakeholders for the assigned marketed products and/or development projects as well as EMA for products under the EU centralized procedure.
Requirements
- Master’s or bachelor’s degree in either pharmacy or life sciences
- Several years of pharmaceutical industry experience in Regulatory Affairs in Human Pharma; any experience in other functions outside of RA would be highly desirable
- Regulatory affairs 'hands on' experience in the region with an understanding for different cultures and their impact
- Practical experience in handling new developments, registrations, and maintenance of registered products
- Outstanding ability in both negotiating and managing projects paired with knowledge of how to interact with health authorities
- Capability and readiness to apply scientific expertise and participate in informed scientific dialogues
- A critical thinker who has the aptitude to self-manage their workload, which includes the ability to reorganize priorities and meet tight deadlines
- Proficiency in English communication, both verbal and written.
Benefits
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Engineer IT Compliance responsible for compliance activities in regulated IT systems. Building partnerships with IT functions and ensuring regulatory alignment in pharmaceutical industry.
Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
Senior Tech Compliance Analyst at Syneos Health responsible for global Technology Disaster Recovery efforts, collaborating with various teams and service providers.
BL
Chief Nuclear Officer serving as the nuclear safety authority for BaRupOn's SMR/MMR programs. Establishing safety frameworks and ensuring regulatory compliance within the organization.
International Trade Compliance Manager overseeing compliance with international trade regulations at Northrop Grumman. Leading a team and managing compliance initiatives across multiple locations in the US.
Compliance Manager leading Autodesk's Enterprise Compliance program. Ensuring compliance with SOX, PCI regulations and overseeing security controls across teams.
Compliance Student supporting compliance and risk management activities for individual insurance at iA Financial Group. Involves monitoring processes, collaborating with teams, and assisting with compliance tasks.
Nurse Licensure & Compliance Coordinator managing multi - state nurse licensure and compliance inquiries while ensuring a positive nurse experience. Advocating for nurses and maintaining regulatory adherence at the organization.
508 Compliance Specialist working with the Office of the Inspector General for the DoD. Responsible for ensuring electronic accessibility for compliance with Section 508 regulations.