Head of Risk & Regulatory Compliance leading risk management and compliance in Meruriyo’s Croatian entity. Ensuring alignment with EU regulatory requirements for crypto - asset services.
About the role
- Regulatory Manager managing CMC projects for GSK, a global biopharma company. Leading regulatory strategies and ensuring compliance across multiple markets in a collaborative environment.
Responsibilities
- Managing people aspects of a team of direct reports to create and sustain an efficient and motivating working environment
- Take accountability for tracking, analyzing and reporting of team performance against departmental KPIs
- Ensure proper escalation for resource or quality considerations
- Independently assess, manage, and/or drive the CMC strategy, coordinate, timely preparation, and author multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the Regional Directives and evolving regulatory requirements
- Understand internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to Localisation projects, and provide guidance to R&D teams, Quality Control, GSC, QA, and LOC
- Ensure adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus
- Ensure adequate contribution during interactions with Worldwide Regulatory Authorities
- Authors responses to Regulatory Agency questions
- Identify risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches
- Contribute to, and lead (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems
- Ensure information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact
- Independently manage the completion of data assessment, ensure all appropriate CMC regulatory aspects, serve as dossier approver, identify improvement opportunities, and confidently execute a dossier that is fit for purpose per agreed dossier strategy and timelines
Requirements
- Master’s degree or higher in a relevant scientific discipline
- Experience in an international regulatory environment or working with multiple markets
- Sound understanding of pharmaceutical industry and regulatory processes with expertise in CMC area
- Project Management experience
- Capability to build and maintain a team
- Fluent English
- Strong interpersonal and communication skills
- Ability to perform multiple tasks, set the right priorities to deliver objectives on time
- Adapting to changing circumstances through priorities reassessment and a disciplined, logical work style
- Exceptional flexibility and growth mindset
- Change management and strong learning agility
- Well-developed leadership skills
- Negotiation and problem-solving skills
- Practical knowledge of risk management
- Veeva Vault knowledge would be an asset
Benefits
- Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office)
- flexible working hours
- Established job in an international, well-known pharmaceutical company
- Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets
- Opportunity to work within GSK standards and documentation applied globally
- Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)
- Supportive & friendly working environment
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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