Regulatory Affairs Specialist - HCM

Typical Accountabilities:

• Maintain in-depth knowledge of key product-related areas, including commercial strategy, dossier content, regulatory intelligence, regulatory timelines, and supply strategy.

• Develop and implement milestone plans for drug registrations.

• Prepare high-quality regulatory submissions and manage product registrations for new applications, license extensions, and variations.

• Develop packaging artwork to support new product launches and lifecycle management.

• Provide detailed updates on the regulatory status of impacted products and advise on appropriate regulatory pathways and processes.

• Maintain regulatory compliance databases and associated processes.

• Monitor registration activities to ensure timely submission and approval of new product registrations, license extensions, and regulatory changes, aligned with company strategic business goals.

• Review promotional materials to ensure compliance with local regulations.

• Manage submissions and approvals for GMP site registrations in a timely manner.

• Prepare high-quality regulatory documentation and respond promptly to DAV and hospital queries to support tender processes.

• Manage regulatory matters related to stock issues efficiently and coordinate with relevant cross-functional teams to help prevent stock shortages.

• Provide regulatory input and comments on draft regulations.

Typical People Management Responsibility (direct / indirect reports):• Approximate number of people managed in total (all levels) - 1-3• Matrix Manager – (projects/dotted line)• Manager of a team

•Grandfather (manager of a manager)

What is the global remit? (how many countries will the role operate in?):• Own countryEducation, Qualifications, Skills and Experience:Essential:

• University Degree in Pharmacy.

• Good command in English skills.

• Knowledge of Pharmaceutical products development process and have strong knowledge and understanding of local regulatory requirements and processes.

• Proactive and highly committed to support and deliver results.

• High Sense of Ownership and accountability for achievement.

• Highly organized and self-disciplined.

• High level of integrity and good morals.

• Analytical skills.

• Self-motivated and good team player.

Desirable:

Working experience at least 2 years in Regulatory Affairs

Key Relationship to reach solutions:• Internal (to AZ or team): Marketing, Sales, KA, Logistics, Medical, Clinical, Global Product Teams, International Regulatory Affairs, Manufacturing Sites and QA, Regional Office, HR, Finance, Corporate Affairs Teams.• External (to AZ): Hospitals and Health Professionals, Regulatory Authorities, Universities, Institutes.

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.