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, who is acting on CSL behalf, 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