Sr Specialist Regulatory Affairs

MSD Malaysia; São Paulo; Presencial; BRL 120 000 - 210 000; Tempo integral

Resumo da oferta

MSD Malaysia seeks a Regulatory Submissions Planner to support LATAM submission planning and regulatory operations across regions. You will manage timelines, coordinate with Country Operations and Health Authorities, and ensure timely delivery of regulatory content.

Required are LATAM regulatory knowledge, strong communication, project management, and IT systems skills to drive efficient submissions in a global team.

Qualificações

• Experience in Regulatory Operations and/or Regulatory Affairs in the pharmaceutical industry.
• Ability to manage multiple priorities with proven project management skills and timelines.
• Thorough knowledge of LATAM regulatory guidelines and procedures.
• Excellent communication in a multicultural environment and ability to coordinate with stakeholders.
• Strong IT systems aptitude to support regulatory content planning and delivery.

Responsabilidades

• Plan, coordinate and review regulatory submissions with country operations and authorities.
• Develop and maintain the regulatory submission plan and project milestones.
• Attend and contribute to relevant planning forums and meetings.
• Collaborate with stakeholders on projects and submissions timelines.
• Drive assembly and delivery of submissions with regional publishers to meet deadlines.
• Maintain regulatory systems/databases for daily operations.
• Identify process improvements to optimize submission efficiency.
• Keep LATAM procedures knowledge up to date with internal/external guidelines.

Conhecimentos

Regulatory operations

Project management

Stakeholder management

Cross-cultural communication

IT systems aptitude

Formação académica

Bachelor’s degree in Life Science or Engineering

Pharmacy degree preferred

Ferramentas

Microsoft Excel

Microsoft PowerPoint

Microsoft SharePoint

Descrição da oferta de emprego

The Regulatory Submissions Planner will be part of the Regional Regulatory Operations team within the Global Regulatory Affairs and Clinical Safety organization of our company. The Regulatory Submissions Planner supports the preparation of regulatory submissions and manages registration tracking from a regulatory operations perspective, ensuring alignment with strategic target dates across the region. As part of a cross-functional team and assigned programs, the incumbent will manage all operational activities from submission planning, and execution of submissions and/or delivery to Health Authorities. This role requires an advance expertise and knowledge of the Latin American countries’ regulatory landscapes, including regional registration procedures and a comprehensive understanding of dossier technical requirements.

Primary Activities

• Planning, coordinating and reviewing regulatory submissions with release to Country Operations teams and/or submission to Health Authorities.
• Responsible for developing and maintaining the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
• Attend and contributes to relevant planning forums and meetings.
• Work closely with other stakeholders on assigned products/projects.
• Drive the submission assembly and delivery process with the Regional Publisher or Global Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions, as per the agreed timelines.
• Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.
• Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement projects.
• Maintain knowledge on the LATAM countries’ procedures (on internal and external guidelines and standards).

Education Requirements

• Bachelor’s degree in a Life Science, Engineering, or a related discipline.
• Pharmacy degree preferred.

Experience and Skills

• Experience in Regulatory Operations and/or Regulatory Affairs within the pharmaceutical industry.
• Able to manage multiple priorities with proven project management skills, including coordinating dynamic timelines, negotiating and collaborating with stakeholders, and consistently following through to completion.
• Thorough knowledge of regulatory guidelines and procedures within the Latin America region is preferable.
• Excellent communication skills to manage interactions with colleagues in a multicultural environment.
• Ability to maintain a clear overview of complex processes involved in planning, managing, tracking, assembling and delivering of regulatory content, to support regulatory strategy, ensure compliance and meet informational needs of internal and external stakeholders.
• Ability to perform effectively under time pressure and to manage the impacts of any delays in timely submissions.
• Aptitude for working with complex IT systems.

Languages

• English
• Portuguese
• Spanish

Preferred Skills

• Proficiency with Microsoft Office applications, particularly Excel, Teams, Power Point and SharePoint.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent people, communication, leadership skills, and well-developed cultural awareness for involvement with cross departmental teams.
• Excellent time and project management skills.

#LaboratoriesBR Required Skills

• Business
• Communication
• Cross-Functional Teamwork
• Global Regulatory
• Government Affairs
• Regulatory Compliance
• Regulatory Operations

#LaboratoriesBR Preferred Skills

• Microsoft Excel
• Microsoft PowerPoint
• Microsoft SharePoint
• Operational Excellence
• Operational Performance
• Process Management
• Stakeholder Engagement

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): no

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.