Regulatory Affairs Jr Manager Technical Director Oncology Specialty
Regulatory Affairs Jr Manager Technical Director Oncology Specialty
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Job Description
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 AbbVies 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 AbbVies desired position.
Technical Director Responsibilities.
- Act as AbbVies 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 AbbVies and Allergans 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.
Qualifications :
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.
Additional Information :
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 AbbVies 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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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
