Regulatory Affair Manager
Full time
at AstraZeneca plc
in
Saudi Arabia
Posted on December 24, 2024
Job details
Location: Jeddah, Mecca Region, Saudi Arabia JOB TITLE: Regulatory Affairs Manager – Saudi Arabia ABOUT ASTRAZENECA: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. ROLE SUMMARY: Responsible for preparation, publication, quality control, and delivery of all submissions. Works on complex technical problems. Acts as regulatory advisor to management and customers on technical research studies and applications. Implements strategies to improve quality and efficiency of submissions. This position covers Saudi Arabia, may be responsible primarily for specific TA, and represent the key point of contact for Saudi market full AZ portfolio. What you’ll do:
- RA strategies for qualitative & efficient submissions:
- Acts 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.
- 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.
- Continuously collaborates with and supports AstraZeneca customers in all regions to gain an understanding of business processes and challenges relative to effective electronic working.
- Develops a system to ensure product safety issues and product-associated events are reported to regulatory agencies.
- Develops and maintains strong partnerships with key global external partners, i.e., Regulatory Health Authorities, Industry Representatives, etc.
- Develops, implements and manages SOPs and systems to track and manage product-associated events.
- Ensures compliance with product post marketing requirements.
- Ensures a system is in place to manage access to information requests.
- Ensures business support needs and Information Systems demands are identified and addressed.
- Ensures Regulatory business needs are incorporated within AstraZeneca’s regulatory systems by being involved in developing requirements, processes, and standards.
- Has personal responsibility for creating a culture of courageous leadership, creativity, and collaboration.
- Identifies potential complex regulatory risks to the global and regional operational plans, and propose options to mitigate risks.
- Implements strategies to improve quality and efficiency of submissions.
- Leads and/or participates in special critical projects (e.g. Regulatory strategy).
- Leads or manages projects or complex products through all stages of the regulatory process, while providing expert advice in specific regulatory areas.
- Leads Submission Management Group and/or cross-functional submission teams for complex, worldwide regulatory applications, ensuring they comply with AstraZeneca’s submission-ready standards.
- Manage processes and personnel involved with maintaining annual licenses, registrations, listings, and patent information.
- Prioritises project-related operational and strategic activities for deployed staff.
- 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.
- 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.
- Provides regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
- Provides supervision, timely & constructive feedback and coaching to AZ colleagues especially more junior Regulatory staff.
- Represents regulatory affairs in product recall and recall communication process.
- 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.
- Reviews and approves required reports and supplemental submissions, advertising and promotional items for regulatory compliance.
- Works as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate.
- Business Partner for county RA agenda:
- Aligning between therapy areas Regulatory Affairs managers and the local agent on all outstanding regulatory activities and keep tracking on it.
- Contact person for any official interaction with authorities.
- Country responsibility on having monthly meeting with our agents regulatory teams in country.
- Regulatory contact person for the country Director/Head.
- Responsible to update systems and global teams on any update on guidelines/or important communications or decrees.
- Corporate responsibility:
- Maintains highest ethical standards and work in a spirit of AstraZeneca Code of Ethics, following rules & norms set by corporate policies.
- Ensures 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.
- Business Awareness/Acumen:
- Applies knowledge of the organization’s products and services to the service offerings.
- Demonstrates a sound knowledge of the industry and commercial environment and uses knowledge of major competitors and markets when undertaking activities.
- Understands how business cases align with organizational strategy and identifies key benefits, costs, and risks and presents them in a format to enable decision making.
- Develops benefits tracking strategies for smaller projects, uses this to prioritize delivery and works with colleagues/suppliers in defining the intended benefits.
- Applies financial management principles to areas of responsibility.
- Initiative:
- Scans the external environment for new ideas and trends.
- Questions the way things are done and drives new and innovative ways to conduct activities & projects.
- Generates opportunities and ideas with stakeholders or authorities which enhance business performance.
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