Regulatory Affairs Manager

2 weeks ago

กรงเทพมหานคร, Thailand Organon Full time

**The Position**

The RAaPV Senior Specialist is responsible for all aspects of regulatory submissions in the assigned markets. Critical to this role is to combine knowledge of scientific, and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Leveraging on expertise in regional regulations, Authority expectations and industry trends, this role will collaborate closely with cross-functional teams to enhance regulatory initiatives, drive regulatory compliance, and support supply continuity.

The Senior Specialist is responsible for all regulatory submission requirements for their assigned product portfolio as applicable including provide and development of product registration plans & strategies and working cross-functionally to review & communicate the registration strategy with management oversight

The Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations as well as company SOPs.

**Responsibilities**:

- Assist and support in development of product registration plans & strategies and working cross-functionally to align & communicate the submission plans.
- Maintain and archive regulatory documents in accordance with department and company policies and local requirements.
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
- Assists in improving local procedures (in compliance with regional and global standards) for the department, to ensure quality RA data and evaluates processes for potential improvement in efficiency and effectiveness.
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Quality and supply chain to avoid supply constraints and ensure constant audit-readiness.
- As delegated, ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply-chain.
- Support the deputy/back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation and will be responsible for supporting local PV activities as assigned.
- Coordinate and oversee regulatory activities across the cluster/region for assigned projects.
- Where applicable, contribute as representative in regulatory associations working groups and/or other regulatory projects from time to time with supervision from manager.

Task
- Technical change management including dossier preparation and compilation
- Label updates and artwork maintenance
- Agency requests with post-marketing samples
- Documentation and archiving of dossiers
- Maintenance of internal regulatory systems
- Support PV activities as assigned and work collaboration with LPVR and Regional PV unit

Competencies
- Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed. Demonstrates advanced skills to drive change and champions development.
- Delivers with accountability: Aligns strategic priorities to team priorities and team resources and delivers results in accordance with timelines and appropriate regulations. Monitor regulatory trends, drives compliance, and proactively manages and mitigates risks to achieve quality outcomes.
- Innovates with agility: Encourages diverse thinking and experiments with new ways of working. Demonstrates advance skills in problem solving using creative thinking, aligning with stakeholders to responds to new, complex, or problematic situations.
- Makes connections: Ability to work in partnership with others (internally and externally) to accomplish quality goals; leads integrated projects and build effective networks.
- Communicates with optimism and authenticity: Articulates a compelling shared vision and communicates with empathy. Demonstrates advanced oral and written communications and presentation skills. Makes timely and appropriate decisions and to determine when escalation of issues is necessary.
- Activates belonging: Reinforces diverse representation and consideration in all talent selection and development activities across teams.

**Required Education, Experience and Skills**:

- The incumbent must have bachelor’s degree in pharmacy / pharmaceutical sciences, a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken).
- Minimum of 5 years of industry experience in regulatory affairs and/or CMC.
- Excellent communication and time management skills, the ability to interface broadly with

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