• Job Summary

• To participate in the planning, defining, implementing and monitoring of appropriate regulatory strategies for lifecycle changes and updates on labelling and artworks, according to the health regulations and company policies.

• To provide accurate and timely information about the products/processes which are under his/her responsibility for the country or countries of responsibility

• To support company on regulatory issues associated with the products under his/her responsibility.

• Single point of contact for Regulatory Strategist Coordinator, Medical information, Commercial, regional labeling and artwork team (Hub Labeling management and ALIM) , Submission Management and third parties within the country for all the activities related to labeling and artworks under his/her scope and also post approval changes for specific countries and type of submissions

• Partners with relevant functional teams, as Supply, Logistics and Business Operations

• Key partner for post approval chances, lifecycle maintenance for regulatory strategist coordinator

• Coordinate and assure the completion of assigned regulatory projects on time within budget and within scope. Prepare reports for upper management regarding status of assigned regulatory projects.

Job responsabilities

Support to Regulatory Strategist Coordinator:

• Execute in timely manner the implementation of strategies for renewals, post approval changes and new indications in the region, according the responsibilities assigned and according of the regulatory strategy defined by the Regulatory Strategist Coordinator and Regulatory Affairs Head.

• Provide to Regulatory Strategist Coordinator the required labeling and artwork for submission of a new product, renewals, line-extension, transfer process, new indications or any other type of submission that requires labeling and artwork as part of the regulatory submission package.

• Assure the update of the local artworks as part of changes in the products as new registration

Document compilation: Assure all the information received for submission is according local regulation, to avoid unnecessary queries and improve approval timelines.

Internal contact interaction: Interaction with the Global and Regional Regulatory Team (GCMC, Submission Management, product principal, Hub strategist, manufacturing plants, medical affairs and other country PCOs) as needed, looking for reduction on submission and approval timelines. Responsible to defined in alignment with Regulatory Strategist Coordinator and Regulatory Affairs Head, strategies to reduce risk on supply continuity in partnership with Supply, Logistics and Business Operations department.

External contact interaction: Submission of post approval changes to local Health Authorities according the responsibilities assigned, coordination with the appropriate teams to assure preparation of LPD/LLD, leaflets and artworks, local registration contact (third parties), looking for follow up of submissions and approval timelines.

Regulatory Archives and data bases: Work directly with above country support to assure all the documents related to submission processes are properly archived in official data bases, to assure information submitted and approved are available. Assure data bases as PEARL, GDMS, Label Central, local tracking tools, local data bases etc. are up to date.

Give support to other departments: Permanent interaction as regulatory reference for Marketing, logistics, supply, Sales, Customer Service, Medical, Safety and Legal to assure the business continuity.

Quality Assurance:

• Assure the quality of the processes associated to the information management that compile the product sanitary registration dossiers.

• Provide support in AQRTs when is required.

• Provide the required support for audit processes related to labeling and artwork management

• Provide support with the updates of local Working Instructions related to labeling and artwork management

Project Participation

• Coordinate the work for the flawless execution of regulatory projects.

• Ensure projects are delivered on-time, within scope and within budget, and according to Pfizer SOPs and Policies.

• Assure the implementation of the detailed project plan and to monitor and track progress.

• Perform risk management to minimize project risks and communicate to Regulatory Affairs Project Lead, as applicable.

• Create and maintain comprehensive project documentation.

• Contribute with the execution of the project, as aplicable.

• Attend conferences and training as required to maintain proficiency.

• Perform other related duties as assigned.

• Develop spreadsheets, diagrams and process maps to document needs.

• According to the Project, make sure that company databases and systems (i.e. PEARL, GDMS) contain the required information and the data is accurate and complete assuring compliance to Pfizer SOPs and Policies.

• Report and escalate to management as needed.

• Complete departmental training in a timely manner to address corporate and regulatory needs.

As applicable, contribute to regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance and innovation.

QUALIFICATIONS/SKILLS

• Academic Degree: Pharmacist

  Minimum experience of one year in Regulatory Affairs or in pharmaceutical technical areas.

• KEY BEHAVIORAL COMPETENCE

  Change management

  Create an inclusive environment

  Keep focus on performance

  Alignment through Pfizer

  Ability to motivate an open discussion for debate

  Ability to handle several projects at the same time

  Capacity to define priorities according stakeholders needs

  Good communication skills.

  TECHNICAL SKILL REQUIREMENTS

  Use of personal computers and more recent programs.

  Knowledge of Local and International Regulations of drugs and its technical aspects.

  Ability to work and understand the technical products information.

  Knowledge of the local and regional pharmaceutical industry.

  Skills in handling and dealing with Health Authorities.

  Quality Focus

  Customer Orientation

  Effective Communication

  Strong working knowledge of Microsoft Office.

  Technical and scientific knowledge of pharmaceutical products.

  Understanding of different regulatory environments.

  Proficiency in English.

  Proficiency in Excel, Power Point and knowledge of systems and databases

• Ability to problem solve.

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.