ADVANZ PHARMA

• Owning Compliance related change controls pertaining license updates and ensuring such changes are progressed and closed within timelines. • Establishing business and Quality needs and criticality for identified license non-compliances and closing license gaps as dictated by this information. • Writing supporting Quality related submission documents, as necessary. • Managing workload appropriately with the ability to re-prioritize rapidly as necessary. • Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritized. • Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant. • Managing associated submission RFIs within timeframe. • Quality Compliance owner for Technical Transfers projects, involving performance of gap assessment between prospective CMO and current registered information and working toward established project timelines. • Liaising with external stakeholders including Contract Manufacturing Organizations and building key relationships. • Quality Compliance SME for Projects owned by both the Compliance team and other departments.

Role Description The Quality Compliance Team within the Quality Department is responsible for ensuring Contract Manufacturing Organizations (CMOs) are provided with current Marketing Authorization information and ensuring that CMOs comply with this information and Pharmacopoeial requirements. This role ensures compliance with registered information and Pharmacopoeial requirements by: - Ensuring license non-compliances as identified through already established Compliance processes are addressed within a pre-defined timeframe based on risk. - Performing Compliance review of new and revised critical Module 3 documents as compiled by Regulatory, prior to submission. The Senior Executive- Quality Compliance has a cross-functional role working closely with Regulatory Affairs, Technical, Operations projects, other Quality functions and CMOs to ensure the above is achieved. Key Responsibilities - Owning Compliance related change controls pertaining license updates and ensuring such changes are progressed and closed within timelines. - Establishing business and Quality needs and criticality for identified license non-compliances and closing license gaps as dictated by this information. - Writing supporting Quality related submission documents, as necessary. - Managing workload appropriately with the ability to re-prioritize rapidly as necessary. - Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritized. - Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant. - Managing associated submission RFIs within timeframe. - Quality Compliance owner for Technical Transfers projects, involving performance of gap assessment between prospective CMO and current registered information and working toward established project timelines. - Liaising with external stakeholders including Contract Manufacturing Organizations and building key relationships. - Quality Compliance SME for Projects owned by both the Compliance team and other departments. Qualifications - Minimum Degree in Chemistry, Pharmacy or Microbiology - Post Graduate Qualification in relevant scientific discipline Requirements - Minimum 5 years' experience of working in a similar role within a pharmaceutical industry - Extensive GxP knowledge across all dosage forms - Experience in authoring Module 3 in CTD format - Experience in interpreting manufacturing and testing information (Critical Vs. Non-critical) for submission purpose - Experience in ensuring that accurate, adequate and appropriate data is incorporated in Module 3 so as to ensure right first submissions - Experience in writing supporting submission documents (e.g. justifications to support post marketing changes and response (to RFI) - Extensive knowledge of QMS, specifically change controls and risk assessments, and continuous improvements - Capable of working to deadlines & remain calm under pressure - Proven ability to organize and prioritize multiple tasks - Ability to work effectively as part of a team and cross functionally - Knowledge of regulatory guidance for variations - Excellent communication skills, both oral and written, to include senior management in third party suppliers - Sound working knowledge of all Microsoft Office applications - Well organized with logical & methodical approach to work - Sound problem-solving skills - Good organization & time management skills Benefits - Professional, methodical approach to work with 'can-do' attitude - Even tempered, positive persona, approachable - Helpful & flexible with strong team spirit - Cultural leader for core values

Role Description As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Medical Advisor – Anti‑Infectives to join our Italian Medical Affairs team. We are looking for a hands‑on Medical Affairs professional with strong anti‑infective content knowledge who can step in quickly and contribute from day one. The Medical Advisor will play a key role in shaping and delivering the national medical strategy for ADVANZ PHARMA’s anti‑infective portfolio in Italy, working closely with local and global stakeholders across the product lifecycle, including pipeline development and future launches. - Develop and execute the national Medical Affairs plan for the anti‑infective portfolio, aligned with global medical strategy - Provide scientific leadership and expertise across marketed products and pipeline assets - Work closely with Medical Affairs, Market Access, Commercial and Clinical teams at local and global level - Build and maintain strong relationships with Key Opinion Leaders, investigators and scientific societies - Lead and support medical education activities, advisory boards, congresses and scientific exchange - Review and approve promotional and regulatory materials to ensure scientific accuracy and compliance - Contribute to evidence generation, publications and medical insights - Thrive in an entrepreneurial environment and take accountability for results - Embrace challenge and change, applying a growth‑mindset approach - Demonstrate a bias for action and fast decision‑making - Consistently embody ADVANZ PHARMA’s core values: Entrepreneurship, Speed and Integrity Qualifications - Scientific degree (MD, PhD, PharmD, Pharmacy, Biology or equivalent life‑science discipline) Requirements - Demonstrated Medical Affairs experience within the pharmaceutical industry - Strong content knowledge and experience in anti‑infectives (essential) - Experience as a Medical Advisor, Senior MSL, or MSL ready to step up - Confidence engaging in scientific exchange with HCPs and external experts - Ability to operate autonomously and manage multiple priorities in a fast‑moving environment - Excellent communication skills in Italian and English - Inspired by ADVANZ PHARMA’s values of entrepreneurship, speed and integrity - Learning agility, with the desire to continuously develop as ADVANZ PHARMA grows - Comfortable working collaboratively across all business functions - Able to thrive in a growing, dynamic and inclusive environment Benefits - Agile working arrangements and a competitive compensation and benefits package designed to support your health, career and work‑life balance - Global recognition programme - Employee Assistance Programme - Birthday leave - Annual Wellbeing Day - Two days’ volunteer leave - Four weeks working from anywhere - Compassionate leave - Long Service Awards

Role Description As ADVANZ PHARMA sharpens its strategic focus towards biosimilars and specialty generics, we have an exciting opportunity for a Clinical Development Scientist to join our Clinical Development team. This role will focus primarily on supporting biosimilars development programmes, working closely with internal teams and external partners to ensure partners clinical strategies and programmes are aligned with regulatory expectations and delivered at pace. This is a hands-on role within a small, high-impact team, offering exposure across clinical development strategy, trial execution, partner governance and regulatory deliverables during an exciting period of growth in the biosimilars space. - Lead clinical development oversight of partner-led biosimilar programmes, including PK comparability, immunogenicity, safety, and efficacy where applicable. - Contribute to clinical development strategy, including study design and programme planning. - Critically review biosimilar clinical development plans and study designs, ensuring they are aligned with current EMA, FDA, UK, and other relevant regulatory expectations. - Review, challenge and refine clinical trial documentation and outputs across biosimilar studies (e.g. PK/PD, immunogenicity). - Support preparation and review of clinical and regulatory documents, including briefing materials, submission modules, and health authority responses. - Collaborate with cross-functional teams including Regulatory Affairs, Medical Affairs, Clinical Operations and Business Development to support portfolio decisions. - Provide scientific input and support to ensure programmes are delivered efficiently and to high quality. - Contribute to a fast-paced, evolving clinical development environment. Qualifications - Advanced degree (MSc, PhD, PharmD, MD or equivalent) in a scientific discipline. Requirements - Working experience in clinical development, clinical science, medical science, or a related role within pharma, biotech, or CRO, including direct work on biosimilar development programmes (essential). - Hands-on biosimilar development experience, including clinical PK comparability, immunogenicity strategy, study conduct, data interpretation, or filing support (essential). - Ability to critically assess bioanalytical and immunogenicity outputs, including PK assay suitability, ADA/NAb data interpretation, sensitivity, specificity, and clinical relevance (desirable). - Experience reviewing or contributing to biosimilar clinical development plans, protocols, SAP input, CSRs, briefing books, regulatory responses, or submission documents. - Practical knowledge of EMA and/or FDA biosimilar expectations, with the ability to stay current with evolving guidance. - Strong understanding of clinical trial methodology from design to reporting. - Experience contributing to clinical and regulatory documentation. - Good understanding of GCP and inspection readiness. - Ability to work effectively in a cross-functional, matrix environment. Benefits - A Culture of Empowerment and Belonging: We foster a workplace rooted in continuous learning, inclusivity, and collaboration. Every voice matters, and we strive to ensure our employees feel valued, respected, and empowered to make a difference. - Flexibility and Support for Your Wellbeing: Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work‑life balance. - Recognition That Inspires: Through our Rewards and Recognition programme, we celebrate the extraordinary contributions of our team members. From outstanding achievements to day‑to‑day excellence, appreciation is a cornerstone of our culture. - Global Benefits: We offer a comprehensive global benefits package designed to support health, wellbeing, and professional growth, including: - Global recognition programme - Employee Assistance Programme - Birthday leave - Annual Wellbeing Day leave - Two days’ volunteer leave - Four weeks working from anywhere - Compassionate leave - Long Service Award

Role Description As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Clinical Development Scientist. This is a senior individual contributor role that provides scientific leadership across partner-led and internally supported development programs within a small, high-impact Clinical Development team. This role is ideal for a clinical scientist with strong expertise in biosimilars/biologics development, who can also contribute to selected small molecules innovative asset programs. - Oversee partner-led biosimilar and biologics development programs, including comparative clinical studies (PK/PD, immunogenicity, safety, efficacy) - Contribute to the clinical strategy development, study design, and protocol authoring (Phases I–III) - Ensure development programs align with EMA/FDA expectations for biologics and biosimilars. - Review and interpret clinical data to ensure scientific integrity and regulatory readiness. - Contribute to clinical sections of regulatory submissions, briefing documents, and responses to health authorities - Build and maintain effective working relationships with global development partners - Support due diligence activities for future development partners, licensing opportunities, and M&A - Provide expert input into study execution, data analysis, and issue resolution to external partner and senior leadership. - Work closely with Clinical Operations, Regulatory Affairs, Patient Safety, and Medical Affairs. - Thrive in an entrepreneurial environment, and take accountability for results - Embrace challenge and change, applying a growth mindset approach - Have a bias for action and fast decision making - Consistently demonstrate and embody company core values: Entrepreneurship, Speed, and Integrity Qualifications - Advanced degree (MSc, PhD, PharmD, MD or equivalent) in a scientific discipline Requirements - Extensive experience in clinical development, clinical science, or a related role within pharma or biotech - Demonstrated expertise in biosimilars and/or biologics development, including: - Comparative clinical studies (PK/PD, immunogenicity) - Clinical trial design and execution - Strong understanding of EMA regulatory requirements - Familiarity with bioanalytical assay development (PK, ADA, NAb) for biologics - Experience contributing to clinical/regulatory documents (protocols, CSRs, Module 2 of MAA dossiers) - Strong knowledge of ICH-GCP and clinical trial methodology - Ability to work independently in a small, fast-moving team - Experience with small molecule innovative programs is a plus - Fluency in English is required; additional European languages are an advantage - A positive and ‘can-do’ approach, biased towards finding solutions and embracing change - Ability to work collaboratively across all business functions with open, honest, and respectful cooperation Benefits - A Culture of Empowerment and Belonging - Flexibility and Support for Your Wellbeing - Recognition That Inspires - Global Benefits, including: - Global recognition programme - Employee Assistance Programme - Birthday leave - Annual Wellbeing Day leave - Two days’ volunteer leave - Four weeks working from anywhere - Compassionate leave - Long Service Award