Regulatory Affairs Jr. Manager & Technical Director – Oncology & Specialty

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

The mission of the Regulatory Affairs Manager is to lead the activities to register and maintain registration of oncology and specialty care products in Chile, cooperating with the Regional Manager, in alignment with business needs, to assure compliance with local regulations and with AbbVie policies.

The Technical Director is AbbVie’ representative before the regulatory authorities in Chile, the link between the company and the regulators, with responsibility over all the pharmaceutical products and the medical products in the AbbVie’s portfolio. The Technical Director is the Agency Point of Contact for Clinical Studies and is also the representative at the Trade Association. It is a mandatory function to operate in the country.

Main Responsibilities

Regulatory Strategies for Oncology & Specialty Care Products in Chile:

• Lead the definition of regulatory strategies for oncology and specialty care products in Chile.
• Keep Area informed on country strategies and requirements.
• Active participation in Brand Teams and other strategic meetings to stay focused in Business needs.

Licenses for Oncology & Specialty Care Products in Chile:

• Manage the registration of oncology & specialty care products, modifications, and renewals, in agreement with the local regulatory framework.

Registries for Oncology & Specialty Care Products in Chile:

• Actively manage the registration of oncology & specialty care products, modifications, and renewals, in agreement with the local regulatory framework. Interact with the Health Authority of Chile, negotiating strategies and acceleration of revisions.

Business Support:

• Support commercial, medical and market access areas during product launches and associated promotional activities, providing robust regulatory strategies. Participate in Brand Team meetings, as required.
• Support business initiatives and the Ethics and Compliance program, efficiently communicating the regulatory perspective.

Trade Associations:

• Actively participate in Trade Association meetings, advocating to achieve AbbVie’s desired position.

Technical Director Responsibilities.

• Act as AbbVie’s technical referent and legally bound responsible before the Regulatory Body. The technical director is legally liable in solidarity with the company, using her or his signature to back up not only the filings but also the importation of products and the release of such products to the internal market.
• Support audits to AbbVie or third parties or attend meetings required by the MoH, as deputy technical responsible.
• Responsibility over pharmaceutical products and medical devices resulting from the integration of AbbVie’s and Allergan’s portfolios.

Others:

• Collaboration in the implementation of programs from the area in the affiliates
• Support and generate initiatives to disseminate knowledge of the regulatory area to other areas of the company.

Training, Education and Experience

• Pharmacist
• 10 years of experience in Regulatory Affairs / Pharmaceutical Industry.
• Strong knowledge of applicable regulations and regulatory strategies.
• English: Advanced Level (FCE).
• Negotiation skills.
• Good communication skills.
• Proactive attitude.
• Skills for teamwork.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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