Regulatory Affairs Manager
AstraZeneca
- Bangalore, Karnataka
- Permanent
- Full-time
- Adherence to AZ and industry codes of conduct, ethics and good regulatory practices
- Ensure that all licensing for assigned products is complete in accordance with relevant norms
- Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch
- Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio
- Competitive Intelligence and analysis
- Align with the values and vision of AZ
- Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement
- Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information)
- Disclose potential breach of codes or conducts
- Monitor status of product licenses
- Project manage changes in product licenses and coordinate with other changes, planned and in progress
- Maintain complete documentation records
- Communicate changes to licenses status promptly
- Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy
- Ensure that local regulatory strategies are consistent with global product strategies and local priorities
- Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time
- Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch
- Strive to ensure high levels of performance and achievements.
- Take decision and accountability for actions.
- Build commitment within the team.
- Enhance positive attitudes and mindset. Demonstrate confidence and conviction.
- Challenge status quo for continuous improvement.
- Help build an open and trusting atmosphere.
- Provide detailed information of regulatory status of affected products
- Undertake assigned follow-up action where necessary
- Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals / permissions
- Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products
- Communicate the impact of changes to key stakeholders.
- Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes
- Develop excellent relationships and partnerships with Regulatory Authorities
- Monitor the global pipelines of competing pharmaceutical companies
- Analyse gathered information for its impact on AstraZeneca proposed pipelines
- Provide scenario with options and a risk – benefit analysis for AstraZeneca going forward