We are growing, grow with us!
Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity!
PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.
The success of our company grows with the excellent expertise and the high motivation of our employees.
If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us.
To strengthen our successful team in Munich, we are looking as of now for a:
Senior Consultant Biopharma Excellence (m/f/d)
- Strategic development of Biopharma excellence service
- Work on a broad range of biopharmaceutical projects (e.g., Cell and gene therapies, biologics etc.) from early development stage to approval
- Preparation of integrated development plans with relevant team members involved
- Support of principal consultants in complex strategic projects in development and approval procedures
- Preparation, review and management of various types of regulatory and scientific documents and submissions to regulatory agencies worldwide (ODDs, PIPs, INDs, CTAs)
- Preparation and conduction of scientific advice briefing documents, procedures and meetings
- Oversight and coordination of project teams for the preparation of regulatory submissions/dossiers
- Training and mentoring of junior consultants
- PhD in a biological or health-related science field such as biology, biotechnology, biochemistry, pharmacy or equivalent experience in the industry
- At least 3-5 years of lead responsibility within the biopharmaceutical industry or agency environment combined with in-depth knowledge in scientific, technical and regulatory development of biopharmaceuticals
- Very good knowledge MS Office skills, knowledge of processes, responsibilities and organizational structures of pharmaceutical companies
- Solution and detail-oriented; well organized and self-motivated
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Exceptional interpersonal skills with the ability to work individually within a multi-
disciplinary team as well as with external partners
- Excellent written and oral communication skills in English
We offer you
- Diverse and challenging job
- Open and appreciative corporate culture
- Flexible working hours based on trust
- Possibility to work reduced number of hours
- Possibility to work from home
- 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 receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms Lena Schlager
Senior Specialist Human Resources
Agencies only by prior agreement for the specific job opportunity.