We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Director, Head of Regulatory Affairs
- Participation in designing the country Regulatory Affairs Department strategy, contribution to all Service Areas, including CMC, e-submission and application management for new submissions as well as for maintenance activities.
- Support to Business Development responsible to drive marketing and business development activities for country clients for all existing Regulatory Services.
- Leadership for acquisition of new customers (RfP coordination, participation in bid defense meetings,…).
- Responsible for driving major new Portugal and if applicable global Regulatory programs in close collaboration with client partners and Regulatory Affairs Department, including responsibility for implementation and continuous improvement of budget, KPIs and other project management tasks.
- Communication and implementation of decisions of the Portuguese management team and of the Regulatory Affairs Department office.
- Representation of departmental interests towards the Regulatory Affairs Department office, including generation, management and reporting on Regulatory country budget, order pipeline and other financial and HR figures.
- Interacts with internal stakeholders.
- Active participation in staffing proposals and decisions for projects within their country and outside their country.
- Responsibility for the working organisation within the country incl. assignment of defined tasks to the employees.
- Economic steering of all assigned projects; support of the business operations in economic steering of the department.
- Operational steering of the department; definition of regulations and processes within the department.
- Clarification of roles, responsibilities and tasks on department level.
- Professional instruction and development of the dedicated employees.
- Technical support and coaching of team members, both from the Regulatory department and other PharmaLex departments, as well as clients, in regulatory specific fields.
- Act as a contact point for Regulatory audits, discuss audits findings and observations and manage the corresponding CAPA plan implementation; ensure the performance of actions based on audit outcomes; follow-up of audits according audit findings and defined timelines; support monitoring of CAPA status and closure.
- Ensure the handling of Regulatory deviations, including the root cause identification and the CAPA implementation and management.
- Continuous professional development of the said team members in these fields.
- Leadership and coaching of the dedicated employees; conduct of probation period, annual employee evaluation and goal setting meetings where applicable.
- Formation of the leadership culture within the department in close cooperation with the country head and with the Regulatory Affairs Department.
- Creation of a motivational working environment.
- Representation of the company and the department towards clients, authorities and associations.
- Build and maintain contacts to companies' representatives.
- Participation in regulatory processes to gain and maintain European and non-European marketing authorisations for human and veterinary medicinal products (application, renewal, variations) with emphasis on submissions aspects.
- General guidance (consultancy) of PharmaLex staff and clients regarding regulatory affairs quality aspects from drug development up to life-cycle management.
- Presenting seminars and lectures PharmaLex -internally, for customers and for professional audience with emphasis on regulatory submission aspects.
- Successful completion of a Master’s Degree or equivalent in pharmacy or other natural sciences.
- Several years of experience and broad knowledge in the field of Regulatory Affiars of human and veterinary medicinal products and health products (medical devices, food supplements and cosmetics). In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs.
- Proven experience in managing cross-functional and cross-country projects, including basic economic knowledge and experience to efficiently and effectively steer the dedicated projects.
- Ideally already experience in leading executives.
- Proficient leadership qualities.
- Capability to analyse problems and to develop possible solutions.
- Capability to motivate employees.
- Capability to professionally represent the country/department and the company both externally and internally.
- Capability to coordinate different projects to be executed in parallel.
- Professional written and verbal communication skills.
- Portuguese and English language fluency. Fluency in another language is an advantage.
- Resilience, willingness to work a flexible schedule and travel.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.