Regulatory Affairs Specialist

hace 15 horas

Xico, México Pfizer A tiempo completo
Why Patients Need You

We're committed to bringing medicines to the world faster, without compromising on excellence and integrity. Adhering to local and global regulations is essential, and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

Interact with key stakeholders and perform activities related to Clinical Trial Application submissions to COFEPRIS. Familiarize yourself with the latest changes in BoH legislation. Support the submissions for Clinical studies (protocols). This includes HA query management.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

Key Responsibilities

  • Possess a thorough understanding of the market requirements for New clinical trials, amendments, permits for import related to clinical trials, as well as the regulatory processes.
  • Work closely with CRO, Compliance oversight, Country SSU head and Finance
  • Routinely monitor Health Agency's website for information related to CTAs. Understand local regulations and trends.
  • Keep current with the BoH legislation
  • Complete departmental training in a timely manner to address corporate and regulatory needs.
  • Responsible for doing all the process to submit protocols, and all the activities related to CTAs: permits for import, payments, variations, answer to queries.

Qualifications

Must-Have:
- Bachelor's Degree
- Experience: About 1 year as Regulatory Affairs Analyst, preferable with clinical trials knowledge

Nice-to-Have:
- Knowledge of local BoH requirements for Clinical trials
- English language
- Team player
- Change agile

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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