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.
Associate Director Regulatory Affairs
- To directly support the Senior Director of Regulatory Affairs
- To provide operational input to Regulatory Affairs projects
- To Provide support to the UK Senior Director, Regulatory Affairs, with regard to:
- business development activities,
- professional and organisational management of the Regulatory Submissions Team
- Supervision and development of employees
- Active participation in staffing proposals and decisions for projects within their department and outside their department.
- Build and maintain contacts to companies' representatives..
- Ensuring that clients’ budgetary expectations are appropriately managed.
- Ensuring that regulatory affairs projects are delivered to exceptional standards.
- Exemplary interaction with regulatory authorities.
- 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.
- Preparation of and participation in Scientific Advice Meetings with regulatory authorities.
- Representation of the company and the department towards clients, authorities and associations.
- Accurate time reporting and supervision of accurate time reporting of direct reports.
- Continuous professional development of team members
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Excellent written and verbal communication skills, with a particular focus on client-facing interactions.
- Educated to at least a relevant science degree level, preferably with a higher degree in a pharmaceutical discipline.
- Extensive experience in pharmaceutical regulatory affairs including practical experience in an R&D discipline.
- Several years of experience and broad knowledge in the field of Regulatory submissions of human and/or veterinary medicinal products” 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.
- Experience in defining and implementation of processes and rules.
- Basic economic knowledge and experience to efficiently and effectively steer the dedicated projects.
- Proficient leadership qualities.
- Capability to analyse problems and to develop possible solutions.
- Capability to motivate employees.
- Capability to professionally represent the department and the company both externally and internally.
- Capability to coordinate different projects to be executed in parallel.
- 25 Days holiday plus BH (increasing to 27 after qualifying service)
- 8% employer pension contribution
- A role that is based in an excellent location with good public transport links and close to local amenities.
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
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 receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.
To apply, please use the "apply now" button below