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.
Head of Regulatory Affairs Germany/DACH (f/m/d)
PharmaLex has an exciting opportunity for a highly motivated and business-minded regulatory professional to lead its Regulatory Affairs function in Germany as well as have significant international responsibility in the PharmaLex Regulatory global practice .
The successful candidate will have the experience and skills to build on our strong reputation for excellence in regulatory affairs. Besides leading the day-to-day activities of the regulatory affairs function, the Head of Regulatory Affairs Germany will also guide other consultant’s projects and contribute his/her expertise to the development of our international clients. Most projects handled by the German PharmaLex organization are global projects, working within our various office locations and partners to manage submissions worldwide.
The Head of Regulatory Affairs will serve as the Germany/ DACH representative in the Regulatory Affairs global practice and hereby contribute to shaping our Global presence. For the international dimension to the position, a very strong track record in new product applications, portfolio maintenance (life cycle management), large global compliance projects or regulatory informatics is desired. Line management experience, favorably also experience in line managing team leaders, and including an advanced ability to lead, mentor, manage and motivate colleagues, first-class communication skills and a diplomatic, client-orientated manner are essential. The minimum qualification is a degree in a relevant scientific discipline and the ideal candidate will have extensive professional experience in regulatory affairs.
The responsibilities of this senior leadership position include:
- Management and Development of the German/ DACH client base and the PLx Regulatory Affairs team in Germany aligned to the strategic plans of PharmaLex
- Ensuring that regulatory affairs projects are delivered to exceptional standards and meet clients’ expectations
- Management of PharmaLex clients, including, but not limited to ensuring that clients’ budgetary expectations are appropriately managed.
- Providing regulatory expertise to regulatory projects being performed by PharmaLex Germany and other international offices.
- Exemplary interaction with regulatory authorities.
- Co-ordination and planning for the efficient operation of the regulatory affairs service team in its international context, including resource planning and pipeline management.
- Accountable to German/ DACH country manager for the operational (including employee utilisation) performance of the Germany’s regulatory affairs function within budget, as applicable.
- Accountable to the EVP Global Head of Regulatory Affairs for input into the global REG strategy, the implementation for all the regulatory affairs services & processes in Germany and the leadership of international projects
- Act as the RA representative in the DACH business development (BD) organisation
- Presenting seminars and lectures to colleagues, customers and other professional audiences.
- Effective implementation of agreed departmental strategies.
- Accurate time reporting and supervision of accurate time reporting of direct reports.
To apply, please provide your CV and a covering letter, explaining how you meet or exceed the specifications for this position and including your salary expectations.
This is a pivotal role in the organisation, reporting to the German/ DACH country manager (Managing Director) and the EVP Global Head of Regulatory Affairs. This is a rare opportunity to make a difference in the rewarding environment of a growing business which is part of a successful and forward-looking international group. The position is located in one of our German offices, preferably Mannheim, Frankfurt, Berlin or Munich area; by the nature of the role, German and international travel can be expected.
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.