Associate Director Regulatory Affairs Innovative Medicine

Overview

Associate Director Regulatory Affairs Innovative Medicines – LondonAbout ADVANZ PHARMAADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. Our portfolio includes innovative medicines, specialty generics and biosimilars, and originator brands across therapeutic areas such as hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and rare diseases. We are committed to our values of entrepreneurship, speed, and integrity and to providing equal employment opportunities for all employees and prospective employees.

Note:

This description retains the original role-specific information and excludes unrelated postings and boilerplate not relevant to this position.About the Role

The Regulatory Affairs Innovative Medicines – Associate Director will assume the role of a Global Product Lead for assigned Innovative Medicines portfolios and be responsible/accountable for all regulatory activities (pre-submission, MAA and post-approval). The role provides strategic regulatory and scientific support on non-clinical and clinical development plans, working with Regulatory Affairs – Strategic Project Leads and Regulatory Affairs Life Cycle Management teams to achieve fast patient access to innovative medicines. This role will be the regulatory point of contact for assigned Innovative assets across the organisation.Key responsibilities include regulatory strategy planning, due diligence for innovative assets (study adequacy, data presentation, risk analysis), coordinating regulatory interactions with health authorities, reviewing Marketing Authorisation Applications (acting as a Regulatory SME for Clinical/Non-Clinical sections), and collaborating with the Strategic Project Team under New Products during MAAs. The role also develops lifecycle strategies and manages post-approval activities in partnership with the LCM team, especially when non-clinical/clinical commitments remain.

What You’ll Do

Strategy Planning – contribute to strategic development decisions for development assets and marketed products in the ADVANZ Innovative Medicines portfolio; assess adequacy of non-clinical and clinical data for regulatory submission with cross-functional risk assessment and external HA interaction considerations.Development planning – contribute to future development plans to support the MAA, including regulatory considerations related to non-clinical/clinical data packages, clinical study protocols, and post-approval safety/efficacy studies.Pre-submission HA Interaction – drive health authority interactions for clinical development, supported by CMC/regulatory experts; coordinate all activities leading to SAM, with Strategic Project teams acting as HA contacts as required.Regulatory Review – participate in review of study synopsis/protocols and key Module sections; ensure accuracy and adequacy of documentation and responses, and review product labeling (SmPC) where applicable.Post Approval – define post-approval strategies (e.g., labeling, PIP strategies under Article 8, market expansions) with support from the LCM team until commitments are fulfilled.About You

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.Qualifications

University degree in a scientific disciplineAdditional Regulatory professional qualificationsExperience and Competences

Regulatory role in submission of New products in Pharma IndustryExperience preparing Common Technical DossiersExperience in submissions/managing National and European MAAs and product launchesExperience with New Chemical Entities applications – preferably Phase 2/3Experience with Generic and Biosimilars applicationsExperience interacting with EU regulatory authorities – scientific advice and pre-submission meetingsExperience handling PIP applications and orphan designationExperience managing Clinical Trial ApplicationsExperience in Medical Devices and their clinical evaluationInternational Regulatory experience – USAKnowledge and Skills

Broad knowledge of European regulatory guidelines and multi-market regulationsStrong understanding of the Drug Development process, including non-clinical studiesExperience supporting NCE registration in EU/UK; clinical development knowledgeExperience with rare/orphan diseases and alternative evidence sourcesExperience using electronic portals for dossier submissions and Regulatory IT systemsStrong project management and matrix-working capabilitiesExcellent communication and interpersonal skills with leadership presenceADVANZ PHARMA is committed to equal employment opportunities for all employees and prospective employees without regard to race, color, religion, sex, age, national origin, ancestry, sexual orientation, marital status, disability, or other protected classifications to the extent required by applicable laws. Reasonable accommodation is available during the application process and on the job where ..... full job details .....