ph3REGULATORY MANAGER /h3 pMCR International | Executive Search /p h3Responsibilities /h3 ul liProvide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in development phase. /li liProvide general regulatory advice and support to other departments. /li liReview and approve promotional and non‑promotional material to comply with local regulation, self‑regulations and internal policies and procedures. Advise the marketing teams on the promotional activities. /li liSupport pharmacovigilance department on safety relevant matters in line with national requirements. /li liSupport the Head of RA with developing and meeting the longer‑term goals for the department. /li /ul h3Main Accountabilities /h3 ul liObtain marketing authorisations for new pharmaceutical products, working closely with area headquarters. /li liMaintain marketing authorisations as required. /li liReview of promotional and non‑promotional materials and activities in accordance with legislation, local procedures and codes of practice. /li liRegulatory advice and support to Brand Team on promotional materials content and activities. /li liKeep updated in current regulations in promotion of medicines and in Spanish Code of Practice for the Pharmaceutical Industry. /li liLiaise and attend meetings with other company functions to provide regulatory advice for new and existing products; participation in affiliate Brand Teams regarding regulatory strategies and proposed label changes, to provide regulatory advice for new and existing products. /li liProvide regulatory support for the Brand Teams commercial divisions in all areas pertaining to product life‑cycle management and new product development. /li liLiaise with European Regulatory Affairs and Corporate groups on regulatory matters. /li liLiaise with national regulatory authorities as required.



/li liMaintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements. /li liComply with the Company’s policies and procedures to ensure consistency of the current local prescribing information with the CCDS in order to: Ensure alignment within the organization. /li liMeet the expectations of regulatory agencies. /li liImplement approved label through defined artwork process. /li liWrite and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable. /li liEnsure compliance with all relevant statutory requirements and all relevant internal procedures. /li liRepresent affiliate regulatory position at defined initiatives or projects from general or area. /li liReviews and is updated in the industry environment (e.g. regulatory, legal, EFPIA and local codes) and provides regulatory position, perspective and expertise related to advertising and promotion to business partners. /li liSupport audits and inspections. /li liKeeps and maintains regulatory operation processes and systems to support regulatory submissions and approvals in the most efficient. /li liKeeps and manages product registration databases to ensure information transmission timely and accurately. /li /ul h3Qualifications /h3 ul liDegree in Pharmacy, Life Sciences or similar. /li li10 years of experience in Regulatory Affairs. /li liStrong knowledge of regulations, and special focus on expertise on regulation of promotion and the Farmaindustria Code of Practice. /li liProject Management and Strategic Communication. /li liThe ability to thrive in a changing environment and to re‑prioritise workload to meet business needs. /li liStrong negotiation skills to build consensus. /li /ul h3Seniority Level /h3 pMid‑Senior level /p h3Employment Type /h3 pFull‑time /p h3Job Function /h3 pOther /p h3Industry /h3 pPharmaceutical Manufacturing /p pReferrals increase your chances of interviewing at MCR International | Executive Search by 2x. /p /p #J-18808-Ljbffr

📌 REGULATORY MANAGER (Madrid)
🏢 MCR International | Executive Search
📍 Madrid