Regulatory Affairs Coordinator

**JOB SUMMARY**: - Participate in the planning of Regulatory strategies for products submissions and lifecycle including also the APIs related to products under responsibility - Coordinate and execute activities related to Dossier planning and submission -paper and/or electronic - for initial registration and maintenance of Drug products including product renewals for the assigned portfolio(s). - Interact with key internal stakeholders, such as Hub Regulatory Strategists, GRA Product Strategists, Submissions Management, GCMC, Quality, PGS and third-party vendors (as applicable), to ensure the regulatory strategies are executed according to the plan to permit the business continuity. - Support the Regulatory Affairs Sr. Managers and Managers (as applicable), in the definition and execution of the regulatory strategies of assigned portfolios. - Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes. **JOB RESPONSIBILITIES**: - Possess understanding of the market regulatory requirements, as well as the regulatory processes. - Coordinate the activities assigned, related to Drug Product submissions and license maintenance and Clinical Trial submissions (as applicable) to Health authorities - Work in partnership with in-country Regulatory teams and key stakeholders including but not limited to the Regional Regulatory Hub Strategy (RRHS), Regulatory Operations, GRA, GPD, GCMC, GSCPM, to ensure the development and implementation/execution of regulatory strategies, to ensure submissions are ready to file, to permit the business continuity and to provide the necessary information to ensure internal systems and databases are updated. - Coordinate the routine monitoring of BoH website for information related to drug product registration, line extensions and post-approval changes status. Understand local regulations and trends. - Ensure that he/she keeps current with the agency legislations, as well as updates the regulatory information on LatAm SP & Pfizer systems/databases (as applicable). - Coordinate and execute the review of submission ready dossiers, ensuring that assigned submissions fully meet the local regulatory requirements. This includes BoH query response. - Support bidding processes by providing updated regulatory documents, as applicable. - Keep updated regulatory electronic systems and tools to share accurate regulatory information with local and above country areas (GCMC, Hubs, local teams, etc.). - Evaluate BoH regulations and its changes, keeping informed as per local processes to the Regulatory team and above country stakeholders. - Review and approval of promotional materials (as applicable), ensuring the compliance with the due SOPs and local requirements. - Collaborate with the labeling and artworks approval processes (as applicable), according to Pfizer procedures and local regulations. - 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. **QUALIFICATIONS**: - Education: Pharmacist graduated or life science degree - Local Regulatory experience - minimum 2-3 years of experience as Regulatory Affairs Analyst (Human Medicinal Products) - Proven ability to consistently deliver on time and quality standards. - Proven ability to manage complex regulatory issues **SKILLS**: - Knowledge of local sanitary legislations and regulatory environment, including Clinical Trials Applications requirements (as applicable) - Technical and scientific knowledge of human pharmaceutical products - Proficiency in the English language - Communication and negotiation skills - Problem Solving - Goals oriented - Understanding stakeholder needs. Customer-oriented - Network and alliance building/ peer relationships - Strong quality and compliance orientation - Analytical Thinking - Ability to work under pressure - Adaptability - Planning - Organized - Team player - Change agile "En Pfizer tenemos el objetivo de ser tan diversos como los pacientes y las comunidades a las que servimos, a través de una cultura vibrante y enriquecida por la mezcla de nacionalidades, identidades, edades, géneros, experiências, tradiciones y capacidades. Estamos comprometidos con atraer talento basándonos en las habilidades y experiências imprescindibles para realizar el trabajo. Si te interesa sumarte a Pfizer, envíanos tu solicitud sin agregar foto, edad, estado civil o cualquier otra información que consideres innecesaria para la posición que estás aplicando. **Trae tu auténtico ser al trabajo - Bring your authentic self to work - “** Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Regulatory Affairs LI-PFE