Specialist, Regulatory Affairs Job - Singapore
Contributes to the execution of registration strategies for medicinal products and medical devices in Singapore and Brunei to ensure timely and successful registration outcome.
- PLANNING: Follow regulatory processes to ensure timely regulatory filing and approval of new products, product line extensions, product labeling updates and quality-related changes. This is to ensure alignment of product availability with business plans and compliance with internal standards.
- STAKEHOLDER ENGAGEMENT: Guide business colleagues on Singapore and Brunei registration and regulatory requirements, liaise with headquarter groups on submission strategies, review and analyse the scientific contents of registration dossiers to ensure compliance with current regulatory expectations and work closely with the regulatory authority to ensure successful regulatory outcomes.
- IMPLEMENTATION: Ensure flawless implementation of the filing plans and facilitate the launch of the new/changed product
- A degree in life sciences.
- At least 3-4 years of relevant commercial regulatory affairs experience and knowledge, with good initiative, good working attitude and good communication/collaborative skills to be able to work independently as well as a team cross-functionally to drive results.
Other Competencies and Personal Attributes:
Business & Finance Acumen
- Demonstrates understanding of financial data and business facts and is able to use the data when making decisions.
- Demonstrates an understanding of changing industry trends, economic drivers and their implications for MSD’s business
Working Across Boundaries
- Demonstrates the ability to use knowledge of teams/functions to help complete tasks and projects
- Demonstrates an awareness of local norms and how they affect the way people work within the organization.
- Demonstrates consideration of individual differences when working in teams.
- Demonstrates the ability to adapt current work processes to meet emerging needs and changes in job responsibilities.
- Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
- Demonstrates an understanding of how function’s goals and strategy aligns with the broader organization’s long-term initiatives
- Demonstrates the ability to coordinate work tasks with others for timely completion and to avoid potential setbacks.
- Demonstrates the ability to adjust work to accommodate sudden task changes and avoid potential threats to meeting task deadlines
- Demonstrates the ability to proactively share information through appropriate media to keep others informed.
- Demonstrates skill in using an open communication style that actively acknowledges other thoughts and opinions.
- Demonstrates ability to craft both written and oral presentations n a way that emphasizes key points and ideas.
- Demonstrates the ability to evaluate data and information to determine accuracy and find potential errors.
- Demonstrates the ability to independently solve problems that arise within job responsibilities and expectations.
- Demonstrates the ability to combine data and information from multiple sources in new ways to determine causes of issues.
- Demonstrates the ability to organize information in a logical way and build on the ideas of others to generate novel approaches to problems.
Discovery & Development Knowledge
- Understands the pharmaceutical business model, the end-to-end pharmaceutical lifecycle, and external marketplace factors
- Understands regulations and standards that govern drug registration
- Applies knowledge of pharmaceutical industry trends, recent innovations, and the disease environment to optimize the success of registration outcome.
Competitive Decision Making & Execution
- Considers the competitor landscape, benchmarks, product benefit/risk profile and recent innovations when formulating recommendations or decisions.
- Consistently operates proactively and competitively to drive optimal decisions and advance the pipeline.
Collaboration & Partnering
- Works independently with internal stakeholders (e.g. across the division, across MSD) to leverage the collective experience, share best practices and diversify thinking.
- Manages existing and navigates new working relationships with external stakeholders e.g. health authorities, regulatory agencies) as defined to support scientific/research activities.
- Contributes to collaboration/partnership dynamics and is able to advocate an objective position or point of view through informal channels and communication techniques.
Business & Operations Management
Evaluates activities and business processes, identifies areas in need of improvement and considers potential solutions or new ways of working.
Able to work with leaders to identify appropriate project, improvement opportunities or tracking of issues
Regulatory & Compliance
- Applies knowledge of MSD policies/procedures and applicable industry regulations and standards to work
- Ability to identify, create, and maintain procedures and documentation that drive high-quality deliverables.
- Demonstrates a deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance
- Adjusts behaviors to drive high quality deliverables.
Job: Regulatory Affairs Generic Job Title:Spclst, Regulatory Affairs
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Regulatory Affairs, Medical, Law, Pharmaceutical, Legal, Healthcare, Science, Research