A Regulatory Affairs Manager at AstraZeneca is responsible for preparation, publication, quality control, and delivery of all submissions. Works on complex technical problems. This position acts as regulatory advisor to management and customers on technical research studies and applications. The role holder implements strategies to improve quality and efficiency of submissions. This position covers Gulf markets (UAE, Kuwait, Oman, Qatar and Bahrain).

Responsibilities of Regulatory Affairs Manager

Core Responsibilities:

• Responsible primarily for specific therapeutic area and/or specific regulatory project/-s. Represent the key point of contact for a specific market/-s on full AZ portfolio in scope of the assigned therapeutic area.
• 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.
• Prioritizes and delivers project-related operational and strategic activities defined by line manager.
• 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.
• Develops 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.

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.
• 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.
• Develops and maintains strong partnerships with key global external partners, i.e., Regulatory Health Authorities, Industry Reps., etc.
• Responsible for the management of the assigned therapeutic area’ skill group such as CMC, labeling updates, regulatory affairs project management, etc.
• 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.
• 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.
• Works as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate.
• Implements strategies to improve quality and efficiency of submissions.
• Leads or manages the life-cycle management projects or activities of complex products while providing expert advice in specific regulatory areas and aligning strategies with line manager.
• Manage processes and personnel involved with maintaining annual licenses, registrations, listings and patent information.
• Ensure compliance with product post marketing requirements.
• Ensures a system is in place to manage access to information requests.

Business Partner for county RA agenda:

• Regulatory contact person for the country Director/Head.
• Country responsibility on having monthly meeting with our agents regulatory teams in country.
• Contact person for any official interaction with authorities.
• Responsible to update systems and global teams on any update on guidelines/or important communications or decrees.
• Aligning between therapy areas Regulatory Affairs managers and the local agent 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
• 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.

Essential for the Role

Following is the desired criteria for the role of Regulatory Affairs Manager at AstraZeneca:

• Completed higher education (pharmaceuticals, medicine, biotechnology).
• Min. 7 yrs working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or in regulatory drug development, product approval/launch, line extension, and license maintenance.

Or

• Experience at a health authority, preferably with min 5 yrs in a multinational company with solid performance contribution.
• Experience managing resource requirements for pivotal projects.

Knowledge & Skills

• Solid knowledge of local and international regulatory standards, requirements, and practices, understanding of business principles, logistics, and finance.
• Excellent communication skills, project and process management.
• Problem-solving skills, basic leadership skills, solid influence skills.
• Excellent negotiation skills.
• Excellent global team working capabilities.
• Knowledge of AstraZeneca business and processes.
• Proven Project Management skills.
• Potential & willingness for people development & management.

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