Regulatory Strategist Coordinator

hace 1 semana

San José, Costa Rica Pfizer A tiempo completo

Organizational Relationship(s)
- Works closely with local PCO BU teams in country and internal stakeholders
- Works closely with above country support as GRA-I LatAm Regional Hub, Hub Regulatory Strategists, GRA Product Strategists, Submissions Management, GCMC, Medical managers and other relevant support areas involved in product registration and product lifecycle management processes

Position Purpose
- Participate in the planning of Regulatory strategies for products submissions and lifecycle 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), These activities include HA query management.
- 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 in order 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.

Primary 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 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.

Technical Skill Requirements
- 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

Qualifications (i.e., preferred education, experience, attributes)
- Education: Pharmacist graduated or life science degree
- Local Regulatory experience
- minimum 4 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

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

Regulatory Affairs

  • Regulatory Packaging

    hace 2 semanas

    San José, Costa Rica ASEPSA A tiempo completo

    ASOCIACIÓN SOLIDARISTA DE EMPLEADOS DE PFIZER Y AFINES IS LOOKING FOR A REGULATORY PACKAGING & LABELING SPECIALIST **ROLE SUMMARY** Colleague fundamentally performs the ePALMS system “Market Coordinator” (MC) role in close collaboration with the Global Regulatory Affairs (GRA) Strategy functions and is the central Regulatory point of contact for the...

  • Regulatory Strategist Coordinator

    hace 1 semana

    San José, San José, Costa Rica Pfizer A tiempo completo

    Organizational Relationship(s)- Works closely with local PCO BU teams in country and internal stakeholders- Works closely with above country support as GRA-I LatAm Regional Hub, Hub Regulatory Strategists, GRA Product Strategists, Submissions Management, GCMC, Medical managers and other relevant support areas involved in product registration and product...

  • Regulatory Affairs Coordinator

    hace 4 semanas

    San José, Costa Rica Viatris A tiempo completo

    3866 Upjohn Export B.V. sucursal Costa Rica At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted...

  • Packaging Labeling Specialist

    hace 3 semanas

    San José, San José, Costa Rica Asepsa A tiempo completo

    ASOCIACIÓN SOLIDARISTA DE EMPLEADOS DE PFIZER Y AFINESIS LOOKING FOR APACKAGING & LABELING SPECIALIST**ROLE SUMMARY**Colleague fundamentally performs the ePALMS system "Market Coordinator" (MC) role in closecollaboration with the Global Regulatory Affairs (GRA) Strategy functions and is the centralRegulatory point of contact for the PGS plants/Artwork...

  • Financial Operations Coordinator Ii

    hace 2 semanas

    San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued. Our high-performance...

  • Finops Coordinator I

    hace 4 semanas

    San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued. Our high-performance...

  • Regional Submission Coordinator

    hace 3 semanas

    San José, San José, Costa Rica Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Finops Coordinator Ii

    hace 3 semanas

    San José, San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success.We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team.Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued.Our high-performance...

  • Finops Coordinator Ii

    hace 2 semanas

    San José, San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success.We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team.Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued.Our high-performance...

  • Finops Coordinator Ii

    hace 3 semanas

    San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued. Our high-performance...

  • Finops Coordinator I

    hace 5 días

    San José, San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success.We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team.Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued.Our high-performance...

  • Finops Coordinator Ii

    hace 2 semanas

    San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued. Our high-performance...

  • Finops Coordinator Ii

    hace 4 semanas

    San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued. Our high-performance...

  • New Business Operations Coordinator

    hace 1 semana

    San Francisco, Heredia, Costa Rica Buzz Media Market A tiempo completo

    **Job Description**, **Business Operations Coordinator** **Professional**The Operations Coordinator will be an integral part of the development of our marketing company.You will be instrumental in ensuring all program/projects deadlines are met with regular communication to all invested parties.This is a fast-paced position requiring a self-driven, motivated...

  • Finops Coordinator Ii

    hace 3 semanas

    San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued. Our high-performance...

  • Latam Countries Third Party Risk Management Coordinator

    hace 3 semanas

    San Francisco, Heredia, Costa Rica Citi A tiempo completo

    The Program Management Lead is a strategic professional who stays abreast of developments within own field and contributes to directional strategy by considering their application in own job and the business. Recognized technical authority for an area within the business. Requires basic commercial awareness. There are typically multiple people within the...

  • Finops Coordinator I

    hace 2 semanas

    San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued. Our high-performance...

  • Finops Coordinator Ii

    hace 2 semanas

    San José, San José, Costa Rica World Fuel Services A tiempo completo

    At World Fuel Services, our employees are the key to our global success.We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team.Our people thrive in an entrepreneurial and culturally-diverse environment, where innovative thinking, collaboration and efficient execution are highly valued.Our high-performance...

  • Payroll Coordinator, Arg-Per-Col Payroll Team

    hace 3 semanas

    San Francisco, Heredia, Costa Rica Amazon Support Services Costa Rica Srl A tiempo completo

    The Payroll Coordinator is responsible for supporting payroll processes across Argentina, Peru, and Colombia, ensuring accuracy, compliance, and timely employee payments.This role involves working closely with local payroll providers, HR, and finance teams to gather, review, and validate payroll data, ensuring alignment with company policies and local labor...

  • Drug Regulatory Affairs Coordinator

    hace 4 semanas

    San José, San José, Costa Rica Sandoz A tiempo completo

    Major accountabilities:- Define the registration plan, and perform product registration activities in accordance with registration and launch plan, & maintain product licenses throughout their life-cycle, in compliance with local regulation and global strategy- Review new projects and define the plan and strategy for their submission and approval in...