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.
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.
Fluent English and Portuguese. Spanish will be desiderable
MSO advanced skills (word, excel, powerpoint)