Programme Manager, Caribbean Regulatory System (CRS)Trinidad and Tobago

Applications are invited from interested and suitably qualified nations of CARPHA Member States.

Programme Manager, Caribbean  Regulatory System (CRS)

The CARPHA/CRS is a regulatory unit with regional responsibilities housed in, and managed by, CARPHA, with technical support provided by PAHO/WHO. The CARPHA/CRS has a mandate from CARICOM’s ministerial health body, COHSOD, to augment but not replace national authorities in their carrying out of medicine regulation, in the specific areas of registration and pharmacovigilance/post market surveillance. The below are expected duties of the CARPHA/CRS Programme Manager, which should be carried out in close coordination with the CRS team, the Head, Medicines Quality Control and Surveillance Department (MQCSD), and the respective PAHO advisor, when needed.

Summary of Responsibilities

1 Regulatory

• Lead and supervise regulatory operations for the CARPHA/CRS, including technical work related to verification procedures, pharmacovigilance and post market surveillance (e.g. receive dossiers, conduct screens, carry out the verification procedure, log, analyze, and respond to adverse events and Substandard and/or Falsified product reports) as well as develop broader policies and strategies related to CRS implementation, in coordination with all relevant CARPHA departments and external partners.

• Organize and manage regulatory workload, including systems for storing files, managing product applications and databases, as well as monitoring CARPHA/CRS performance metrics, such as timelines, in accordance with performance goals.

2 Communications

• Carry out operational and strategic communications with Member States and industry on CRS matters.

• Carry out advocacy duties as the CRS representative to internal and external stakeholders, including development of draft technical and policy documents, presentations at key forums, and other related duties.

3 Policy/strategy

• Lead regular technical and/or policy meetings with CARPHA/CRS team to agree on key regulatory policies, which may include new protocols, new guidance, and decisions regarding recommendation of products.

• Other duties as necessary including contributing to CRS strategy among broader CARPHA programme and performance goal setting.

Education (Qualifications)

A graduate level degree in a medicine-related field, such as pharmacy, medicine, public health (with a focus on medicines policy or regulations), pharmacology, or pharmaceutical sciences.

Experience

Seven (7) years or more years’ experience in regulatory or pharmaceutical policy / practice, particularly in a government setting is desired.

Kindly visit our website for further information.

https://www.carpha.org/More/CARPHA-Talent-Acquisition