Regulatory Affairs Lead, HP, ROPU ASKAN
7 months ago
The Position
Provide guidance and support to the local Regulatory Affairs in implementing sound regulatory strategies and risk mitigation plans for.....
The Position
- Provide guidance and support to the local Regulatory Affairs in implementing sound regulatory strategies and risk mitigation plans for assigned portfolio and alignment of regulatory submission plans with business strategies in the ROPU.
- Maintain full awareness of all regulatory activities of assigned portfolio and work closely with global and local teams to ensure project deadlines, performance and compliance standards for assigned portfolio are met throughout a product’s entire life cycle.
- Act as regulatory expert to the global/ROPU/local teams on regulations, guidelines interpretation within the ROPU and communicate regulatory issues impacting BI portfolio to implement timely actions.
- Support local Regulatory Affairs in maintaining a strong network with the health authority, pharma association and other key regulatory influencer and stakeholder, influencing the regulatory project strategy and promoting BI’s interests.
- Actively participate in roll out of regulatory compliance activities for assigned portfolio according to local regulatory requirements and to internal standards and support the effective implementation of harmonized processes across the ROPU.
Tasks & Responsibilities
1. Regulatory Planning and Submission Strategy
- Support the development and execution of global regulatory strategies for assigned portfolio within the agreed timelines and guide local Regulatory Affairs personnel in developing innovative submissions strategies to accelerate regulatory processes on key indications/brands.
- Assess and communicate major regulatory issues relating to clinical, technical, strategic or operational information impacting BI portfolio and implement regulatory measures in liaison with regional and global team.
- Establish an effective and collaborative working relationship with cross-functional teams; prepare and present concise status updates of assigned portfolio as required.
2. Quality and Compliance
- Establish tracking systems and processes for timely submission of CCDS, CRC, Renewals, PSUR and other local variations to maximize the business opportunity or mitigate the operational risks.
- Conduct training and ensure maintenance of databases.
- Contribute to CAPA process as appropriate and support inspection readiness.
3. Regulatory Intelligence and Policy
- Support local Regulatory Affairs in maintaining a strong network with the health authority/reviewers/pharma associations and influence into the regulatory project strategy.
- Act as regulatory expert to global/ROPU/local teams on regulations, guidelines interpretation within the ROPU and provide consolidated overview on key regulatory development with cross functional integration to Regulatory Intelligence Network.
4. Operational Excellence
- Support an effective implementation and maintenance of harmonized processes and systems across ROPU, avoiding duplication of global processes.
- Provide feedback to global on the implementation of global initiatives and suggest improvements to current processes
- Engage in assessment of training needs and mentoring of the local regulatory affairs to implement appropriate training/development plans and promote sharing of best practices
Requirements
- Degree in Medicine or Pharmacy or related life sciences discipline
- At least 8 years of experience with multinational pharmaceutical company
- At least 5 years of experience in various aspect of Regulatory Affairs (e.g. NDA, renewal, lifecycle management etc.) for innovative pharmaceutical products
- Knowledge of regulatory affairs regulations in the region is preferred
- Demonstrated ability to communicate and coordinate within an international setting
- Experience working effectively across cultures and in complex matrixed environment
- Experience in participation and working with local pharmaceutical association
- Excellent verbal and written communication style at all levels; English proficiency required
- Strong interpersonal and management skills with business acumen
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