Regulatory Affairs Coordinator

Organizational Relationship(s) including to whom the position reports (JD Job Title): Direct Report to Regulatory Affairs Head / Sr. Manager / Manager (as applicable) Organizational relationships:
- 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 including also the APIs related to products under responsibility
- Coordinate and execute activities related to 1) Dossier planning and submission -paper and/or electronic
- for initial registration and maintenance of Drug products including product renewals for the assigned portfolio(s), 2) Clinical Trial Applications, for country acceptability in terms of content, according to local regulations and requirements (as applicable). 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 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. Manage Clinical Trial Approvals
- Working with Regulatory Country Lead/Team, liaise with clinical research project managers to seek to understand clinical research program.
- Ensure timely communication of any GCP breaches, oractions taken for safety reasons.
- Along with the Country Lead/Country Team, contribute to enhance the relationships with Regulatory Authorities and trade associations with the objective to promote and facilitate clinical development in the country. 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 agil