Regulatory Affairs Analyst

Posted 2 Days Ago
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San Jose, Escazu, Escazu
Hybrid
Junior
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
The Regulatory Affairs Analyst will assist in developing and implementing regulatory strategies for labeling and artwork changes, ensuring compliance with health regulations. This role requires coordination with various teams to manage submission processes, maintain regulatory archives, and support the business's continuity with accurate regulatory information. Project management and communication with health authorities are key components of the position.
Summary Generated by Built In
  • 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 r egulatory 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.


Work Location Assignment: Hybrid
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
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The Company
HQ: New York, NY
121,990 Employees
Hybrid Workplace
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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