When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Main Responsibilities and Accountabilities of RPR:
Strategy (execution) & (partner) management
- Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
- Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities
- Act as point of contact for escalations and issue resolution related to partner activities
- Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations
- Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs
- Keep internal data bases up to date with local activity and ensure compliance KPIs are adequately kept on track
(Internal) stakeholder management and trainings
- Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, has the appropriate interactions with HAs.
- Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance.
Parexel-related Responsibilities
Meets established metrics as specified in scorecard on an annual basis
Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management
Defines self-development activities to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)
May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and/or author articles.)
Skills:
Fluent in local language, English, oral and written
Expert MS Office skills
Excellent organizational, time management and interpersonal skills in a global environment.
Ability to work successfully in a complex global matrix organization.
Proven ability to work effectively both independently and in a team.
The expertise, determination and courage to resolve or escalate issues as appropriate.
Subject matter expert in job area typically obtained through advanced education and work experience.
Knowledge and Experience:
Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
Partner management experience: proven experience in managing relationships with third-party vendors,
Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive
Education:
Relevant bachelor’s degree or equivalent secondary education in e.g., , natural sciences (biology, chemistry or pharmacy), or regulatory affairs
Advanced degree (Master’s or PhD) preferred in e.g., business natural sciences (biology, chemistry or pharmacy) or regulatory affairs
