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, we are looking for a:
Manager Regulatory CMC (f/m/d)
- Provision of flexible Regulatory CMC services for a variety of clients on a range of product types and dosage forms for human and veterinary medicinal products
- Consultation regarding specific questions referring your area of expertise
- Critical review (gap analysis, due diligence) and authoring of CMC documents (e.g. CTD Modules 3 &2.3, IMPDs/INDs, Variations, Technical and Scientific Reports, Expert Statements
- CMC focused project management
- Strategic CMC regulatory and development support
- Preparation for and participation in communication procedures with regulatory authorities such as pre-submission and scientific advice meetings with emphasis on CMC aspects
- Response to enquiries and comments from regulatory authorities such as deficiency letters
- Liaison and cooperation with internal and external project teams, clients and partners, often in a multinational and global setting
- Successful completion of a Master’s Degree or equivalent in pharmacy or other natural sciences
- Life science/biotech industry experience is a plus, ideally with hands-on experience in biologics development or regulatory affairs
- English language business fluency
- Professional experience in CMC activities incl. authoring and review of CMC documents
- Sound knowledge of current pharmaceutical and regulatory requirements with focus on CMC (EU, ICH and ideally also non-ICH)
- Willingness to expand knowledge in complementary fields of expertise
- Analytical and structured thinking and working
- Ability to adjust to new, challenging situations
- Convincing and confident appearance
- You are a team player, communicative, conscientious, accurate and responsible
- Confident use of MS Word, Excel, as well as database and document management systems
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 taking over this most challenging job opportunity in our future-oriented company and want to develop as well as our company, we look forward to receiving your application documents stating your earliest possible starting date and salary expectations online.
For further information please don’t hesitate to contact us:
Senior Specialist Human Resources
Agencies only by prior agreement for the specific job opportunity