Assoc Dir, Reg Affairs, Doc

hace 3 semanas

Ciudad de México MSD A tiempo completo

**Job Description**:
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

**Responsibilities**:

- Manages the investigations according to our company standards and local procedures and acting as primary contact with regional Q&C team.
- Monitoring of critical systems; ORION, RISE, CPI, USPT, REDS, RADAR to ensure the compliance of the local team and/or initiate investigations for non-compliance
- Closely cooperates with local External QA team for GMP site inspections, delivery of regulatory documents for vaccines release and annual product review.
- Ensures the monthly reports of KPIs to ensure compliance, promote continuous improvement and share with whole RA local team for alignment and required improvements.
- Preparation of pre-work and primary contact for internal/external audits.
- Ensures efficient and implementation in compliance of internal and external regulatory databases, systems, processes and procedures in the country.
- Ensures the correct archiving of product files and coordinate the sending of the expired documents to external vendor.
- Ensure the on time updating of SOPs through a formal annual program in compliance with HQ procedures, policies and local regulations
- Provides training on regulatory (processes, timing etc.) to stakeholders as applicable.
- Active participation in regional Q&C council meetings.
- Keeps abreast of local and international laws, collects relevant publicly available regulatory information, provides insights, and responds to consultations on proposed local regulatory guidance, as appropriate, and communicates final regulatory guidance for awareness and impact assessment, in cooperation with Global Regulatory Intelligence
- For new regulations, identifies and tracks changes/trends that might impact regulatory processes.
- Participates in task forces of Pharmaceutical Industry/Agency.
- Ensures the validity of GMPs/CPPs required for local regulatory and government processes, through the CAST system and Tenders Survey.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

**Who we are **

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for **
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R227134

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