JOB SUMMARY
- Support the Regulatory team in the activities associated to new product registration and post approval changes during product lifecycle for the assigned portfolio
- Work in collaboration across the Cluster / Country (as applicable) to deliver efficiencies in regulatory submissions and processes.
- Interact with local Regulatory Teams, Regional Hub Teams, PGS, GCMC, GRO (e.g.: SM, PPLS, CDM, GRRS) and key local and regional stakeholders (as applicable) in order to fulfill the assigned responsibilities
- Familiarize with the latest changes in BoH legislation.
JOB RESPONSIBILITIES
- Possess a thorough understanding of the Cluster/Country (as applicable) market requirements, as well as the regulatory processes.
- Work closely with the local Regulatory team, LatAm Regional Hub and other stakeholders as applicable (e.g. PGS, Submission management, GRO, GCMC) to support the execution of the Regulatory Strategies associated to initial submissions, line extensions and post approval changes
- Provide the necessary information to ensure internal systems and databases are updated.
- Work with local team with reference to the evaluation of data received from the Headquarter and other areas of the company for elaboration of technical reports. Partner with Regional Hub and PGS as applicable to perform this evaluation.
- Participate in the discussion and preparation of HA query responses, working in partnership with local Regulatory Team, Regional Hub and above country stakeholders.
- Routinely monitor Health Agency's website for information related to product registration, line extensions and post-approval changes.
- Understand and keep current with reference to local regulations and trends.
- Collaborate with the process of timely communicating, new regulations and trends as well as RRM maintenance.
- Keep updated all Pfizer's systems, share points and control spreadsheets related to all registration activities.
- 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 and talent development and retention.
Qualifications
- Experience: Regulatory Jr. Analyst, pharmaceuticals for humans- minimum 1 years
- Education: Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science
- Certifications: N/A
SKILLS
- Change agile
- Knowledge of local BoH requirements, as well as the requirements for the markets in the Cluster
- Technical and scientific knowledge of pharmaceutical products
- Proficiency in the English language is preferred
- Team player
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
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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