Senior Regulatory Affairs Consultant

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