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
- Providing a wide range of flexible services within regulatory affairs for different clients in a range of different product types, marketing authorization types and therapeutic areas.
- Regulatory intelligence.
- Planning and management of regulatory submissions and procedures with a focus on post-authorisation support. Includes advising clients of best strategy and navigating clients through the processes in addition to hands-on activities required to prepare and submit documentation.
- Providing regulatory submission/procedure management and CMC expertise to a variety of regulatory programs and projects being managed by PharmaLex PT or other international offices.
- Representation of clients at regulatory authorities including acting as the primary contact point and facilitating in teleconferences and face-to-face meetings with regulatory agencies.
- Participation in business development activities for PharmaLex Portugal and international group.
- Successful completion of a Master’s Degree or equivalent in pharmacy or other natural sciences
- Extensive professional experience in evaluation, preparation and compilation of regulatory documents, quality documentations and/or extensive experience in regulatory processes (registration procedures, renewals, variation procedures)
- Autonomous, concentrated and high-quality work
- Ability to deliver and effectively manage strategic goals for the business as well as strategic goals of partnerships with clients; ability to balance client requests, employee and company interests
- Strong understanding of the business economical areas to adequately prepare and/or support the preparation of proposals/RFP responses for clients
- Structured, analytical, systematic and independent way of working
- Ability to adjust rapidly to new, unknown, challenging situations; delivery of strategic outputs and actions consistent with operating policies
- Lead extensive process reengineering activities and provide consultation related to change management
- Proactively identify and manage up/cross selling opportunities
- Ability to analyse problems and propose solutions at a business level
- Ability to lead large and/or complex project teams, distribute work equally and according to team member's strengths, developing and motivating both junior and experienced colleagues; convincing others in difficult change management situations
- Ability to work in a team
- Ability to manage internal and external client relationships on client's department head level; ability to convey strategic goals of collaboration and be an ambassador for the company.
- Excellent communication skills (written and verbally)
- Proven capability to communicate critical issues, analyse and propose appropriate solutions to decision makers and business heads.
- Excellent presentation skills
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.