Assoc. Scientist, Regulatory Affairs

3 semanas atrás

São Paulo, São Paulo, Brasil MSD Tempo inteiro
We are seeking an Associate Scientist to join our team in supporting regional Chemistry, Manufacturing and Control (CMC) strategy, the preparation of documentation, and the execution of regional post-approval submissions and new product registrations. In this role, you will serve as a vital link between Regional and Local Regulatory Affairs and Product Teams.
**Key Responsibilities**:
- Assess regulatory change control by identifying requirements for submissions.
- Track submissions and approvals, ensuring bidirectional communication of status with local regulatory colleagues and global teams.
- Review documentation to support submissions according to local and regional requirements.
- Assist in timely responses to Health Authority queries, ensuring compliance with local and regional regulatory requirements.
- Attend cross-functional meetings, providing input on local and regional requirements and maintaining close communication with local regulatory colleagues and global teams.
- Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
- Provide input on continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practices.
- Stay informed about local and regional regulatory policy trends while maintaining the regulatory intelligence repository for regional markets.
- Identify, communicate, and escalate potential regulatory issues to management as needed.
**Main Requirements**:
- Bachelor's degree in life sciences, chemistry, pharmacy, or a related field.
- Advanced English skills - reading, writing and speaking.
- Previous experience in the area of Chemistry, Manufacturing and Control (CMC) Regulatory Affairs;
- Previous experience supporting digital initiaves for CMC Regulatory Affairs is strongly preferred.
- Strong teamwork skills and the ability to communicate effectively with various stakeholders.
- Knowledge of local regulatory requirements and the ability to stay updated on industry trends.
- Proactive problem-solving skills in dynamic environments.
- Familiarity with product registration processes and lifecycle management.
- Availability to work in a hybrid model in São Paulo/SP.
LI-DNI
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
No
**Travel Requirements**:
No Travel Required
**Flexible Work Arrangements**:
Hybrid
**Shift**:
1st - Day
**Valid Driving License**:
No
**Hazardous Material(s)**:
n/a
**Job Posting End Date**:
11/15/2024
**Requisition ID**:R322199

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