Manager, Regulatory Asset Oversight

Gsk; Xico; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical company located in Xico, Veracruz, is seeking a Regulatory Asset Oversight Manager to oversee regulatory strategies and ensure compliance throughout the submission lifecycle. The ideal candidate will have a degree in a relevant field and experience in project management within a regulatory environment. Outstanding communication skills and the ability to lead multidisciplinary teams are essential. The role offers a collaborative work environment and the opportunity to contribute significantly to innovative healthcare solutions.

Servicios

Opportunities for professional development

Collaborative work environment

Commitment to high-quality results

Formación

• Degree or experience in drug development.
• Project or submission management experience in R&D.
• Good understanding of pharmaceutical industry and R&D processes.
• Experience overseeing multiple regulatory activities.
• Knowledge of Regulatory Affairs from pre-IND through Post-Approval.
• Ability to lead multi-disciplinary meetings effectively.
• Good written and verbal communication skills.

Responsabilidades

• Develop and maintain a holistic view of the global regulatory plan.
• Drive execution of plans to ensure compliance with regulatory strategies.
• Assist RMTs with submission delivery strategies.
• Coordinate meetings and logistics for cross-functional engagements.
• Utilize regulatory technologies to provide submission statuses.
• Identify and remove barriers to successful filing strategies.

Conocimientos

Project management

Regulatory affairs knowledge

Communication skills

Multidisciplinary teamwork

Analytical thinking

Educación

Degree in a biological, healthcare, or scientific discipline

Herramientas

Regulatory technologies

Project management systems

Descripción del empleo

Job Purpose

Join Our Team as a Regulatory Asset Oversight Manager!

Details (Your Responsibilities)

In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan.

• Drive the execution of the agreed plans to ensure team is on-track to deliver per the Global Regulatory
• Strategy (GRS), performing scenario planning, impact analyses, critical path analyses and facilitate risk mitigation in response to any issues / risks that arise.
• Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions.
• Employing a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.
• Proactively partner as a Single Point of Contact with RMTs and Submission Delivery Excellence colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.
• Coordinate the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success ensuring logistics, agenda topics and meeting materials are available and organized for the use of the team.
• Proactively identify upcoming activities or milestones which might impact regulatory deliverables and escalates of issues and blockers to Sr.

Manager, Regulatory Asset Oversight, and leadership as required.

• Utilizes Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets.
• Contributes to Regulatory Asset Oversight function metrics and KPIs.
• Leverages data from RIM systems to support RMT needs, ensuring its accurate, complete, and fit for purpose.
• Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion.
• May serve as SME inputting to WoWs in conjunction with Stakeholders with a focus on continuous improvement, identification and implementation of automation opportunities, and compliance with Regulatory authority requirements
• Networks with peers and colleagues to further develop required skillset.

Why You?

Basic Qualifications

• Degree in a biological, healthcare, or scientific discipline or experience within the drug development environment
• Project or submission management / coordination experience in an R&D environment; Regulatory Health Authority requirements
• Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Experience in the pharmaceutical industry or in a regulatory environment, overseeing and prioritizing multiple activities across multiple assets.
• Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval.
• Knowledge of project management and resource management systems, tools, & reporting features
• Ability to effectively lead multidisciplinary team meetings drive discussions regarding, timelines, resource allocation, risk management, etc.
• Good written and verbal communication skills and ability to present information in a clear and concise manner.
• Ability to effectively interact through different levels in the regulatory organization and with stakeholders outside of regulatory with ability to persuade and influence others (regardless of level) in achieving team objectives.
• Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.

Preferred Qualifications

• Professional experience in a Submission delivery or Project Management role
• Regulatory Submission delivery or Project Management

Why GSK?

• Our values and expectations are at the heart of everything we do and form an important part of our culture.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness
• This is a job description to aide in the job posting but does not include all job evaluation details.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positiv