Martha Cifuentes

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REGULATORY AFFAIRS DIRECTOR & QUALIFIED PERSON

Al Pharma S.A.S

Apr 2022 - Current (4 years 1 month)

Scope Led cross-functional teams in Regulatory Affairs, Quality Assurance, and the Compounding/mixing Center for a hemato oncological portfolio across 11 countries in Central and South America (Colombia, Ecuador, Perú, Panamá, EL Salvador; Costa Rica, . Oversaw the development and execution of therapeutic solutions involving synthetic drugs, biologics, biotech drugs, orphan drugs, and medical devices. Serve as primary liaison with the Regulatory authorities and representing the company at Industry Trade Associations and Project management for the implementation of projects to comply with regulatory requirements. • Led the automation of the Regulatory Affairs department by integrating AI solutions and electronic tracking and data repository

REGULATORY AFFAIRS AND QUALITY ASSURANCE MANAGER

Genomma Lab

Jul 2020 - Apr 2022 (1 year 10 months)

• Lead regulatory affairs and quality assurance teams in the process of submission, approval, Andean recognition and variations of marketing authorizations for drugs and personal care products in Colombia , Ecuador and Perú • Monitoring the compliance implementation of change controls associated with regulatory life cycle management. • Interact and negotiate with health authorities during regulatory submissions, inspections and other interactions to ensure successful outcomes. Achievements: • Secured regulatory approval for the renewal of marketing authorizations for 58% of the commercially active portfolio (80% of Pareto products), ensuring compliance through the controlled implementation of change controls in manufacturing, packaging artw

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REGULATORY AFFAIRS COORDINATOR

MERCK S.A

Nov 2018 - Jul 2020 (1 year 9 months)

• Regulatory management of the cardiometabolic care and general medicine portfolios, ensuring the necessary processes to submission of new marketing authorization, new indications, renewals and variations approvals, and general life cycle management of marketing authorizations for Merck in Colombia. • Regulatory support to countries in Central and South America, such as regulatory liaison in product expansion projects generated by the local CMO. ◦ Representing the company at Industry Trade Associations Achievements: • To get agreements with the health authority for fast-track review and approval of market authorization variation related to the update of the Merck "brand look" in all drug portfolios. • Leading the innovation in regulato

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REGULATORY AFFAIRS AND QUALITY ASSURANCE MANAGER

LUMINOVA PHARMA GROUP - GRUPO UNIPHARM S.A|

Mar 2015 - Nov 2018 (3 years 9 months)

• Managed regulatory affairs for Andean and Central American countries, overseeing human and veterinary marketing authorizations across oncology, antibiotics, antifungals, antiretrovirals, analgesics, respiratory treatments, personal care products, food supplements, and medical devices portfolios. • Conducted impact assessments on regulatory information, gathered and analyzed regulatory intelligence, and developed regulatory transition strategies, integrating them into cross-divisional planning. • Serve as primary liaison with the Regulatory authorities Achievements: • Led a merger project between AMA de Colombia and Grupo Unipharm, including regulatory planning, submission, approval and implementation of variations in the marketing authori

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REGULATORY AFFAIRS MANAGER AND TECHNICAL DIRECTOR

AMA DE COLOMBIA C.I LTDA.

Jul 2009 - Mar 2015 (5 years 9 months)

Develop the overall management of the Regulatory Affairs activities to conducive to approval of marketing authorizations for drugs and medical devices of human and veterinary portfolios. • Leading the new market authorization approval for oncology portfolio (45 products) each one in 5 territories of Andean and Caribbean countries (Colombia, Ecuador, Peru, Costa Rica and Panama).

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