Regulatory Affairs Manager – Argentina & Colombia
Abbott · Bogota
Descripcion del puesto
About the role
The Regulatory Affairs Manager leads the Regulatory Affairs sub‑function, focusing on policy implementation and operational control across Argentina and Colombia. The role ensures timely product registrations and ongoing compliance throughout the product lifecycle.
Key responsibilities
- Oversee strategy implementation and day‑to‑day operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
- Interact with regulatory agencies to expedite approval of pending registrations and serve as the regulatory liaison.
- Participate in product plan development, regulatory strategy, risk management, and chemistry‑manufacturing‑control (CMC) activities.
- Advise development and marketing teams on manufacturing changes, line extensions, labeling, and regulatory interpretations.
Required profile
- Minimum 7 years of experience in regulatory affairs within the pharmaceutical, biologics, or medical device sector.
- Associate degree (or equivalent) with approximately 13 years of total professional experience.
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Publicado hace 15 horas
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Abbott
Bogota
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