Regulatory Affairs Senior Specialist, Regional CoE

Astrazeneca Pharma India Ltd.; Riyadh; Presencial; SAR 180 000 - 300 000; Tempo integral

Resumo da oferta

Astrazeneca Pharma India Ltd. is seeking a Regulatory Affairs professional to oversee LCM planning and delivery, dossier preparation and customization, and coordination with iRAMs, iRADs, and iCMC teams to ensure timely submissions.

The role requires managing HAQs, tracking approvals, overseeing labeling and MAH activities, and maintaining regulatory systems while ensuring compliance with global procedures and market-specific requirements.

Qualificações

• Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering or related discipline.
• Minimum 4 years of regulatory affairs experience in biopharmaceuticals.
• Strong knowledge of post-approval submissions and local requirements.
• Ability to collaborate with MC teams, iRAMs, iRADs and iCMC across functions.

Conhecimentos

Project coordination

Attention to detail

Problem-solving

Written communication

Stakeholder management

English proficiency

Formação académica

Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering

Descrição da oferta de emprego

LCM Planning and Delivery

Plan and execute assigned LCM activities in line with market plans agreed priorities internal objectives local requirements and applicable global procedures

Dossier Preparation and Customization

Compile and customize submission dossiers including country-specific Module 1 content national forms declarations cover letters administrative documents and supporting records nbsp

CMC and Non-CMC Content Coordination

Coordinate with international iRAMs iRADs and iCMC teams to identify content gaps and ensure timely availability of approved source documents and technical responses

Submission Execution

Execute or support the timely submission of dossiers according to the market operating model including administrative steps and submission evidence where applicable

Health Authority Query HAQ Management

Monitor review milestones anticipate Health Authority questions and coordinate complete consistent and timely responses with MC and international partners

Approval Tracking and Implementation

Obtain and track LCM approvals or notifications and coordinate implementation of variations renewals commitments and other post-approval changes including PSURs PBRERs and safety data cutoffs

Labeling Coordination

Manage label customization artwork coordination implementation workflows compliance verification and maintenance of labeling where applicable

License Maintenance and MAH Activities

Support product license maintenance operational MAH-related activities and divestment or transfer activities for asigned products

Translation Management

Coordinate translations of Health Authority communications approvals and dossier components with final validation provided by the responsible MC

Regulatory Systems Maintenance

Maintain accurate and timely records in RIM ERV and other required regulatory systems in accordance with established procedures standards and KPIs

Regulatory Intelligence

Apply relevant LCM regulatory intelligence through approved channels escalating changes that may impact strategy content timelines supply or compliance

Reporting and Risk Management

Provide transparent status reporting risk escalation and decision records to MC teams CoE leadership iRAMs iRADs and iCMC teams

Continuous Improvement

Contribute to the development of standard templates playbooks dashboards automation initiatives and lessons learned to reduce duplication of effort and workload for MC teams

Essential Capabilities

• Education: Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Regulatory Experience: Minimum 4 years of relevant experience in biopharmaceutical regulatory affairs, including hands-on experience supporting assigned products and preparing country-specific dossiers.
• Technical Knowledge: Strong knowledge of post-approval submissions, local administrative requirements, Health Authority query management, approval implementation, and regulatory data maintenance.
• Cross-Functional Capability: Ability to work with both CMC and non-CMC content and collaborate effectively with MC teams, iRAMs, iRADs, and iCMC teams.
• Professional Competencies: Strong project coordination, attention to detail, problem-solving, written communication, and stakeholder management skills.
• Language and Working Environment: Proficiency in English and the ability to operate effectively in a multicultural, matrixed, and high-volume environment.