REGULATORY AFFAIRS ASSOCIATED/MANAGER FOR GRS PORTUGAL
Bristol-Myers Squibb Company
Madrid - ES
hace 37 días

Main Responsabilities

Registration and Clinical Trials

  • Maintenance of a centrally approved product and management of local regulatory processes for these products.
  • Submission and follow-up of all regulatory submissions to national authority, including any kind of submissions related to clinical trial applications, and regulatory submissions for nationally approved marketing authorizations.
  • Interpretation of local guidelines to ensure that regulatory documentation will meet the requirements of the relevant authorities.
  • Support the European Regulatory Teams, especially to ensure local requirements are considered in the strategy plans, when required.
  • Driving and support of local projects, cross-functional or regulatory global projects and department related assignments.
  • Primary contact with national authorities to deal with regulatory and related issues regarding the company products, including support for local implementation of Risk Minimization Plans (and Educational Materials) : lead filing and approval with local Health Authorities, in coordination with PV and Medical functions.
  • Development of the necessary external contacts with Portuguese Health Authorities, Trade Associations etc.
  • Archiving of regulatory files and documentation and maintenance of regulatory databases / spreadsheets.
  • Obtaining, providing and interpreting Regulatory Intelligence, especially for Portugal.
  • Provide regulatory affairs contribution to product launch activities and Cross-functional Product Country Brand Teams / Workstreams in accordance with business objectives.
  • Ensuring continuous update of contry SmPCs / PILs according to Company Core Data Sheets (CCDS)
  • Liaises with the Technical Operations, Quality and Supply Chain groups to anticipate and resolve any potential supply or quality issues.
  • Identification, planning and implementing initiatives to improve the effectiveness of the department.
  • A&P (Advertising and promotion)

  • To review and approve A&P materials in line with the relevant codes of practice, internal BMS requirements and Portuguese regulations.
  • Provide regulatory support and advice for the development and preparation of company materials and activities in line with the previous mentioned codes, BMS requirements and regulations.
  • Regulatory compliance

  • Preparation and maintenance of required and relevant regional or local SOPs and associated process documents
  • Dissemination of new or amended product information to local company employees.
  • Review and approval of new or amended packaging components in line with the products licenses for the products marketed locally.
  • Core Competencies :

  • Analytical skills to identify the best scenarios and recommendations for the Company
  • Capability to develop international project management skills.
  • Potential to handle several projects in parallel.
  • Ability to develop successful business partnerships.
  • Translates broad strategies into specific objectives and action plans.
  • Develops contingency plans and meets challenges necessary to execute business and action plans.
  • Background and skills required

  • Minimum of 3 years work experience in a similar position in a Regulatory Area in a pharma company in Portugal.
  • Qualification in the Areas of Competence listed above
  • Bachelor Degree in Pharmacy or similar Life Science Degree
  • Understanding of the entire drug development process from creation to submission for final approval, including clinical and pre-
  • clinical pharmaceutical manufacturing.

  • Knowledge of European regulatory requirements for the Pharmaceutical industry, including specifically the interpretation of Portuguese regulations as they apply to the commercial need of the Company.
  • Understanding of European regulatory legislation and processes.
  • Demonstrated experience in timely management of high quality regulatory submissions and relevant approval, together with experience on regulatory support to business strategy.
  • Long standing experience in directly interacting Health Authorities
  • Experience of working on multidisciplinary project teams.
  • Experience of working in a team (also remotely) environment.
  • Customer orientation
  • Fluent English and Portuguese. Spanish will be desiderable
  • MSO advanced skills (word, excel, powerpoint)
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