Regulatory Affairs And Scientific Service Senior Manager

Puesto: REGULATORY AFFAIRS AND SCIENTIFIC SERVICE SENIOR MANAGER
** MISSION/SUMMARY
** Reporting to the Associate Director Regulatory Affairs & Pricing, the mission of this role is to ensure regulatory compliance excellence across the MC Spain company’s portfolio. The role acts as a key enabler of regulatory strategy and operational efficiency directly supporting the business unit’s (Health Care, CNS, Derma) goals and ensuring alignment with national  addition, this role will be responsible for the scientific and promotional materials review in order to ensure compliance with the relevant regulation, under the supervision of the Head of the Scientific Service.
** CORE RESPONSIBILITIES
**** Regulatory Strategy*
* · Define, propose and execute regulatory strategies for new registrations, variations, renewals, and lifecycle management, for medicinal products and other OTC
· Identify regulatory risks and propose mitigation plans.
· Ensure alignment with national, European, and international regulations.
· Provide affiliate support to corporate projects with regard to national regulatory planning, local data, and regulatory support for Spain‑specific procedures.
** Dossier Preparation, Review & Submission*
* · Prepare, review, and manage regulatory submissions including new marketing authorizations, variations, line extensions, and renewals for medicinal products and other OTC.
· Coordinate documentation with CMC, Clinical, QA, PV, and Supply teams.
· Review core product documentation (SmPC, PIL, labelling, CMC) to ensure regulatory compliance.
** Interaction with Health Authorities*
* · Act as the main liaison with regulatory authorities (e.g., AEMPS, Gencat and other local authorities).
** Acting as a parter of the quality assurance for communications with HA*
* · Manage MAH authorizations, including new applications and amendments.
· Manage import and export permits for medicinal products
· Notification of shortages
** Regulatory intelligence*
* · Conduct regulatory intelligence and assess the impact of new legislation in the company’s portfolio.
· Participate as a regulatory expert in meetings with other internal departments, external companies, or health authorities.
· Monitor publications in official databases, ej: AEMPS, EMA, Bifimed, CMDh, to have the most updated information regarding legislation and new medicines arriving on the market.
** Scientific Service manager
** Under the supervision of the Head of the Scientific Service, this role will be responsible for:
· Review promotional and scientific materials in accordance with applicable laws and ethical codes.
· Notification to Gen Cat when needed.
· Ensure alignment with approved product information and regulatory requirements.
· Collaborate with Marketing and Medical Affairs to ensure ethical, compliant messaging.
** Support with Pricing activities*
* · Track price lists published by the Ministry of Health and assess their potential impact on the company’s portfolio.
· Local price coordinator: keep updated the prices in the internal pricing tool
· Monitor MoH publications
** REQUIRED EDUCATION AND EXPERIENCE*
* · University degree in a relevant discipline such as Pharmacy, Life Sciences (Biology, Chemistry, Biochemistry)
· Valuable Master’s degree or Postgraduate studies in Pharmaceutical Industry or Health Economics
· High level of English is required
· Minimum of 5 years of professional experience in a similar role in the pharmaceutical industry
· Deep knowledge in Regulatory, Pricing, Scientific Service
** PREFERRED SKILLS & COMPETENCES*
* · Deep knowledge of national and EU pharmaceutical regulations.
· Experience in the revision of promotional materials.
· Experience in pricing and reimbursement procedures in Spain.
· Strong analytical skills to interpret regulatory changes and assess their impact on the business.
· Excellent communication abilities, both written and verbal, to interact effectively with internal stakeholders and health authorities.
· Attention to detail and high level of accuracy in regulatory documentation and pricing dossiers.
· Project management skills, with the ability to prioritize tasks and manage multiple deadlines.
· Strategic thinking, with a proactive approach to identifying regulatory and pricing…