Regulatory Affairs Specialist for Oncology and Specialty Care
hace 1 día
AbbVie seeks a highly skilled Regulatory Affairs Specialist to lead the registration and maintenance of oncology and specialty care products in Chile. This role requires close collaboration with the Regional Manager to ensure compliance with local regulations and AbbVie policies.
The Technical Director will serve as AbbVie's representative before regulatory authorities in Chile, facilitating communication between the company and regulators while ensuring adherence to all pharmaceutical and medical product portfolios. Key responsibilities include:
- Defining regulatory strategies for oncology and specialty care products in Chile
- Communicating country-specific strategies and requirements to Area teams
- Active participation in Brand Teams and strategic meetings to align with business needs
This role involves managing licenses for oncology and specialty care products in Chile, including registrations, modifications, and renewals according to local regulatory frameworks. The successful candidate will interact with the Health Authority of Chile to negotiate strategies and expedite revisions.
In addition to technical expertise, the ideal candidate should possess excellent communication skills to support commercial, medical, and market access areas during product launches and promotional activities. They will participate in Brand Team meetings and efficiently communicate the regulatory perspective to support business initiatives and the Ethics and Compliance program.
The Technical Director will also actively participate in Trade Association meetings, advocating for AbbVie's desired position and representing the company's interests.
Required skills and qualifications include:
- 10 years of experience in Regulatory Affairs or the pharmaceutical industry
- Strong knowledge of applicable regulations and regulatory strategies
- Advanced English language proficiency (FCE)
- Excellent teamwork and collaboration skills
AbbVie offers a competitive salary range estimated at $120,000 - $180,000 per year, commensurate with experience. Additional benefits include:
- A comprehensive health insurance plan
- A 401(k) retirement savings plan
- Flexible work arrangements and professional development opportunities
We are an equal opportunity employer committed to diversity and inclusion. We strive to create a work environment where everyone feels valued and respected.
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