Regulatory Affairs Manager Astrazeneca Pharma India Ltd.

RA strategies for qualitative & efficient submissions:

• Leads Submission Management Group and/or cross-functional submission teams for complex, worldwide regulatory applications, ensuring they comply with AstraZeneca s submission-ready standards
• Proactively solicits information from the Global Regulatory Lead, plans and monitors execution of submissions related activities
• Provides expertise, guidance, and awareness to the product teams, skill groups and global functions in support of dynamic Health Authority Regulatory requirements
• Continuously collaborates with and supports AstraZeneca customers in all regions to gain an understanding of business processes and challenges relative to effective electronic working
• Ensures business support needs and Information Systems demands are identified and addressed
• Prioritises project-related operational and strategic activities for deployed staff
• Ensures Regulatory business needs are incorporated within AstraZeneca s regulatory systems by being involved in developing requirements, processes and standards
• Leads and/or participates in special critical projects (e.g. Regulatory strategy)
• Provides knowledgeable, professional, and interactive representation on industry or internal forums to ensure AstraZeneca s Regulatory interests and requirements are communicated and incorporated into key decisions
• Develops and maintains strong partnerships with key global external partners, i.e., Regulatory Health Authorities, Industry Reps., etc.
• Responsible for the management of a section of a skill group such as CMC, regulatory affairs project management, etc. Responsible for skill development, performance management, resource allocation.
• Provides supervision, timely & constructive feedback and coaching to AZ colleagues esp. more junior Regulatory staff
• Identifies potential complex regulatory risks to the global and regional operational plans and propose options to mitigate risks.
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
• Act as an expert resource to product development teams to resolve more complex regulatory issues and ensure the success of all elements of the regulatory process
• Works as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate.
• Implement strategies to improve quality and efficiency of submissions.
• Leads or manages projects or complex products through all stages of the regulatory process, while providing expert advice in specific regulatory areas.
• Manage processes and personnel involved with maintaining annual licenses, registrations, listings and patent information
• Ensure compliance with product post marketing requirements
• Reviews and approve required reports and supplemental submissions, advertising and promotional items for regulatory compliance. labelling to ensure compliance
• Ensures a system is in place to manage access to information requests
• Develops, implements and manages SOPs and systems to track and manage product- associated events
• Provides regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance
• Develop a system to ensure product safety issues and product-associated events are reported to regulatory agencies
• Represent regulatory affairs in product recall and recall communication process
• Conducts additional tasks as assigned by Line Manager per business need. Normally expected to conduct basic people management responsibilities: coaching, developing others, supervising, managing & guiding regulatory professional in the absence of Line Manager.

Business Partner for county RA agenda:

• Regulatory contact person for the Head and related BUDs.
• Contact person for any official interaction with authorities.
• Responsible for updating systems and global teams on any update on guidelines/or important communications or decrees.
• Aligning between therapy areas Regulatory Affairs managers on all outstanding regulatory activities and keep tracking on it.

Corporate responsibility:

• Maintains highest ethical standards and work in a spirit of AstraZeneca Code of Ethics, following rules & norms set by corporate policies
• Ensure that all conducted activities are done in accordance with local legislation and corporate standards.
• Timely reports (as per respective procedures): health/environment/wellbeing related accidents; adverse events that you became aware about; change in status of your Conflict of Interest.

Business relationship management

• Develops strategic and collaborative relationships with external stakeholders and works with them to achieve joint objectives with AZ.
• Maintains an up-to-date understanding of all developments & dynamics of the authorities & key institutions which may affect the organization s operations and policies and proactively advises internal stakeholders of all relevant matters.
• Addresses the engagement needs of key stakeholders through tailored interactions.
• Collects and analyses relevant data, using appropriate methodologies, and offers practical solutions and advice which meet stakeholders requirements.

Conceptual Thinking

• Fits information into mental models and frameworks.
• Makes connections between facts and events that are not really obvious.
• Recognizes how one situation may be affected by another and thinks of the implications of actions on other tasks/projects.
• Relates different pieces of information and recognizes trends.
• Understands how own tasks relate to the wider framework.
• Compares present data and events with previously defined frameworks.

Strategic Thinking

• Associates information in order to analyze a situation.
• Takes a longer-term view and considers future needs.

Evaluation and analysis

• Identifies information sources
• Supports others with data collection and analysis