Senior Regulatory Affairs Manager

JOB TITLE  

Senior Regulatory Affairs Manager

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 mgt and customers on technical research studies and applications. 

Implements strategies to improve quality and efficiency of submissions  

This position covers Gulf markets (UAE, Kuwait, Oman, Qatar and Bahrain).

May be responsible for specific therapeutic area/-s and/or specific regulatory project/-s, and represent the key point of contact for a specific market/-s on full AZ portfolio in scope of the assigned therapeutic area.

What you’ll do

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
• Prioritizes 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
• 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 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
• 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. 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 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.

Only applications based in UAE will be considered.

Essential for the role

• Completed higher education (pharmaceuticals, medicine, biotechnology), potential & willingness for people development & management
• Min. 7-9 years 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, min 5 years in multinational company with solid performance contribution
• Solid knowledge of local and international regulatory standards, requirements and practices, understanding of business principles, logistics, finance, excellent communication skills, project and process management, problem solving skills, basic leadership skills, solid influence skills

Desirable for the role

• Experience managing resource requirements for pivotal projects
• Excellent negotiation skills
• Excellent global team working capabilities
• Knowledge of AstraZeneca business and processes
• Proven Project Management skills

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.