Senior Regulatory Affairs Consultant - Labelling Strategy (home or office based)
PAREXEL
Overview
In this role you will lead labeling strategy within Global Regulatory Affairs to align CCDS, dCCDS, USPI and EU SmPC across products. You will influence product development plans, ensure compliant labeling and support commercial opportunities. You’ll collaborate with GRA, GCD, GCSP and cross-functional teams to maintain global consistency and governance. This is a senior, strategic position with global impact, available in multiple European locations or remote.
Responsabilità- Lead development and maintenance of dCCDS, CCDS, USPI and EU SmPC for assigned portfolio.
- Provide labeling strategy input to early development and ensure alignment with regulatory and development plans.
- Contribute to study design documents, Investigator Brochures and Briefing Books from a labeling perspective.
- Coordinate with SMEs across GCSP, GCD, GRA and CDO to finalize CCDS content and labeling.
- Oversee CCDS-USPI/SmPC exception assessments via Global Labeling Committee processes.
- Represent Global Labeling in internal/external meetings and maintain cross-functional communication.
- Stay up-to-date with global labeling requirements and regulatory expectations.
- Build and maintain cross-functional networks across GRA and R&D/Commercial teams.
- University degree in Life Sciences or related Pharmaceutical field
- Minimum of 10 years’ biotech/pharmaceutical industry experience, incl. 6+ years in labeling/regulatory roles
- Knowledge of regulatory principles relevant to drug development and post-marketing labeling
- Strong ability to interpret scientific documents and translate into labeling content
- Proven problem-solving, risk assessment and decision-making capabilities
- Proficient understanding of drug/biologic development from pre-clinical to post-clinical labeling implications
- Effective communication skills for diverse audiences, including complex concepts
- Attention to detail with strategic thinking
- Fluency in English (verbal and written)
- Strong communication and stakeholder management
- Strategic thinking and impact orientation
- Cross-functional collaboration
- Global labeling knowledge (dCCDS, CCDS, USPI, SmPC)
- Regulatory affairs expertise in drug development
- Ability to translate science into labeling content
Offerta di lavoro pubblicata 2 giorni fa
Offerte di lavoro simili
- ...Overview In this role you will lead labeling strategy within Global Regulatory Affairs to align CCDS, dCCDS, USPI and EU SmPC across products. You will influence... ...global consistency and governance. This is a senior, strategic position with global impact, available in...Home officeSeniorRemoto
- ...you will support worldwide post-approval regulatory activities focused on CMC for vaccines... ...within a regulatory team to shape submission strategies, assess quality-related changes, and... ...equivalent Experience in regulatory affairs, especially technical/CMC/quality in pharma...Home officeOrario flessibile
- ...department, combining strategy, creativity, and... ...As a Growth Senior Analyst , you will... ...projects and strategies to drive Fever's... ...Experience in strategy consulting, investment... ...business impact based on your decisions... ...Hybrid work setup: home office friendly with a central...Home officeSeniorLavoro ibridoLavoro da casaOrario flessibile
- ...Aufgaben und Verantwortlichkeiten As a Senior Regulatory Affairs Expert, you will play a key role in ensuring regulatory compliance and product... ...applicable regulations, including product classification, labeling, packaging, and registration requirements. Providing...SeniorPermesso di lavoro
- ...are seeking an experienced Regulatory Affairs professional to lead... ...combination products regulatory strategy. In this pivotal role, you... ...teams. The role can be home or office based in various European... ...comprehensive regulatory strategies and technical documentation...Home office
- ...Overview As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine... ..., QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Your work supports variations...Home officeSeniorRemotoOrario flessibile
- ...IQVIA in Milan seeks a Senior Consultant to join the Management Consulting team. You will develop and deliver multiple consulting projects... ...focusing on Commercial Excellence, Go-to-Market and Launch strategies, portfolio optimization, and buy/sell-side advisory. You...Senior
- ...act as the internal technical authority for the digital ecosystem. You will govern cross-platform integrations, blend high-level strategy with hands-on development, and ensure adherence to security standards and group guidelines. /ppThe role drives the integration strategy...Senior
- pstrongConstruction Engineer - Head Office (Milano) | Oil Gas EPC /strong... ...Engineer /strong to be based in their head offices in Milan... ...and definition of construction strategies in line with project requirements... ...work class /liliCoordinate home office construction activities...Home officeSeniorLavoro da casa
- ...hire a bConstruction Engineer /b to be based in their head offices in Milan. /p pThe selected candidate... ...and definition of construction strategies in line with project requirements, contractual... ...and work class /li liCoordinate home office construction activities for one or...Home officeSeniorLavoro da casa
- ...a long-term business strategy since its founding in... ...under construction in its home market. Furthermore,... ...markets - through its office in Rome. /p pLet's work... ...out by third-party consultants /liliSupport the management... ...and actively monitor regulatory developments that may...Home officeSeniorStage/TirocinioLavoro da casa
- ...Prysmian is seeking a Transformation Office Senior Analyst to join our Milan HQ, reporting to the Head of Transformation Office. The role... ...and operational transformation initiatives, bridging strategy and execution to support leadership decisions. You will work...Senior
- pAlfasigma in Milan, Italy, seeks a Senior Director, Biostatistics Lead to drive statistical strategy across therapeutic areas and clinical development. You will provide SME input on plans, study reports, and regulatory submissions, and you will lead a talented biostatistics...Senior
- ...Alfasigma is seeking a Senior Director, Biostatistics Lead to guide biostatistical strategy across clinical programs. The role influences... ...plans, study design, and regulatory submissions, partnering with... ...high-quality results. Based in Milan or another EU country...Senior
- ...deliver measurable data improvements. You'll shape data strategy with leadership support, and tackle forward-... ...learning and development allowance location-based benefits flexible work arrangements home office support perks tailored to location autonomy...Home officeSeniorOrario flessibile
- pPublicis Groupe in Italy is seeking a Content Strategy Lead to join our Content team in Milan. Reporting to the Head of Content, you... ...agency environments. /ppYou will define and drive social media strategies across a portfolio of clients, lead workshops, mentor a team...Senior
- ...Towers Watson in Milan is seeking a Senior Analyst in General Risk Consulting to deliver analytic insights under... ...Analytics. You will advise on risk finance strategies, review data, and develop financing... ...capabilities, and fluent English. Base salary ranges with a 7.5% annual...Senior
- ...Pegasystems, Milan-based, seeks a senior enterprise seller to lead a cross‑functional Client Growth team across the enterprise sales cycle.... ...via proactive hunting within strategic accounts and own deal strategy end to end, with support from adjacent teams. You’ll...Senior
- ...Sompo Holdings, Inc. in Milan is seeking a Senior Underwriter Property to lead positioning in the local market and manage multinational... ...across functions to develop an innovative underwriting strategy and help grow Sompo's presence in Continental Europe. #J-18808...Senior
- ...Agoda’s Design team invites a Product Designer L2 / Senior Product Designer to drive cross-sell and recommendations across user touchpoints... ..., and scalable experiences. This hands-on role sets UX strategy, leads complex initiatives, and ensures intuitive, scalable...Senior
- A leading management consulting firm in Italy is seeking a Cyber Security Manager to join their Business Resilience & Digital Risk team. The role involves defining Cyber Security strategies, conducting risk assessments, and implementing compliance measures. Candidates...SeniorLavoro ibridoOrario flessibile
- ...Red Hat, Inc. is seeking a Senior Partner Sales Account Manager to drive growth with Global System Integrators in Italy. Based in Milan or Rome, the role partners with executive... ...to craft joint business plans and GTM strategies, expanding Red Hat adoption across customer...Senior
- pYAM is seeking a Senior Strategist (B2B) to lead business-focused communications for clients in Italy and internationally. You will shape content, media approaches and KPI-driven strategies across digital and traditional channels, collaborating with strategy and creative...Senior
- pWolters Kluwer Milano is seeking a Sales Strategy Associate Director to partner with the GM and Sales Leadership to drive strategic... ...function. /ppYou will translate objectives into scalable commercial strategies, lead forecasting and pipeline governance, and collaborate...Senior
- pLSC Lifesciences Consultants Inc. in Milan, Italy, seeks experienced Strategy Consultants to tackle complex challenges for biopharma and med-tech clients. You will... ...-sciences projects. /ppJoin a fast-paced, merit-based environment offering accelerated learning, diverse...Senior
- ...BCG Platinion in Milano area seeks a senior IT strategy consultant to bridge strategy and technology. You will lead and deliver high-impact IT projects for financial clients, shaping architecture and roadmaps, and work with executive stakeholders to turn ambitious ideas...Senior
- ...Platinion is seeking a Lead IT Architect to work with clients on IT strategies and architecture solutions. You will be responsible for end-to... ...into performance. Requirements include 10-15 years of experience in software development or technology consulting, a /p #J-18808-LjbffrSeniorLavoro ibrido
- pBCG Platinion, part of The Boston Consulting Group, leverages strategy and technology to deliver AI‑driven solutions and platform architectures for leading organizations. You will independently acquire and manage strategic IT projects, guiding clients from planning through...Senior
- ...BCG Platinion is seeking a seasoned IT strategy and delivery professional in Italy to help lead complex technology initiatives for top... ...projects, manage multi‑disciplinary teams, and present outcomes to senior client executives. You’ll collaborate across borders with...Senior
98.800 €
...%. You will shape end-to-end employee and labor relations strategies and advise senior EU Operations leaders on experience, compliance, and risk.... ...RME, 3P Transportation, and Scale projects, this role is based in Europe with CCNL Dirigenti classification and a base salary...Senior