Regulatory Affairs Mgr. Ctas

Regulatory Affairs Mgr. Ctas




Regulatory Affairs Mgr. Ctas

Detalles de la oferta

Organizational Relationship(s) including to whom the position reports (JD Job Title):
Reports to Head of Regulatory Affairs of the Country or Cluster
Position Purpose
Lead, manage and provide strategic direction to the development and execution of regulatory strategies related to Clinical Trial Applications, for country acceptability in terms of content, according to local regulations and requirements. This includes HA query management.
Ensure the interaction with key stakeholders, such as the PCOs, Hub Regulatory Strategists, Product Strategists, Submissions Management, Global Product Development, and third party vendors is in place, to ensure the regulatory strategy is executed in a timely manner.
Familiarize themselves with the latest changes in BoH legislation, and communicate this to all relevant stakeholders, to ensure the necessary systems and databases are updated as necessary.
Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes.
Primary Responsibilities
Lead and manage the development of regulatory strategies and execute them to support the registration of clinical trial applications, drug product registration and maintenance.
Possess a thorough understanding of the market regulatory requirements, as well as the regulatory processes.
Coordinate the activities related to Clinical Trial Applications and Drug Product submissions to Health authorities and license maintenance
Work in partnership with key stakeholders including but not limited to the Regional Regulatory Hub Strategy (RRHS), WRO, WSR, GPD, GCMC, GSCPM, to ensure submissions are ready to file, and provide the necessary information to ensure internal systems and databases are updated.
Ensure the coordination of routine monitoring of BoH website for information related to drug product and CTA registration status. Understand local regulations and trends.
Ensure the Regulatory team keeps current with the agency legislations, as well as updates the regulatory information on LatAm SP & Pfizer databases (as applicable).
Coordinate the review of submission ready dossiers, ensuring that submissions fully meet the local regulatory requirements. This includes BoH query response.
Work in partnership with the PCOs, RRHS and stakeholders, as applicable.
Review and ensure processes related to exportation documents.
Support bidding processes by providing updated regulatory documents.
Contact the BoH by elaborating documents, e-mails, phone contacts and meetings for following-up processes of registration approval.
Complete departmental training in a timely manner to address corporate and regulatory needs.
As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation.
Manage Clinical Trial Approvals (if performed in country)
Liaise with clinical research project managers to seek to understand clinical research program.
In partnership with above-country operational hubs, above-country WSR strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries.
Ensure timely communication of any GCP breaches, or actions taken for safety reasons.
Influencing The Regulatory Environment- CTAs
Along with the Country/Cluster Lead, work in enhancing the relationships with Regulatory Authorities and trade associations with the objective to promote and facilitate clinical development in the country.
Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.
Utilize local knowledge of Regulatory Authority’s expectations, ways of working etc to appropriately direct company strategy. Share updates with colleagues.
Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network.
Respond to spontaneous requests from authorities promptly and accurately.
Work with authorities if Pfizer position differs from authority position in order to obtain a better outcome for the business/patients.
Technical Skill Requirements
Knowledge of local BoH requirements, including Clinical Trials Applications requirements
Technical and scientific knowledge of pharmaceutical products
Proficiency in the English language
Decision making
Development of colleagues
Team player
Change agile
Qualifications (i.e., preferred education, experience, attributes)
Certifications: N/A
Education: Pharmacy or life sciences degree
Experience: More than 5 years as a Regulatory Affairs Coordinator. Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products) and in Clinical Trial Applications.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Ciudad: mexico city

Fuente: Neuvoo_Ppc


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