Regulatory Affairs Specialist CMC (m/f/x) | Stuttgart area | Pharma
Your ambition is to get to know regulatory affairs "out the box" and to exercise it holistically? You like a very dynamic and innovative atmosphere in a well-supported startup environment? Do you not only work strictly according to job description and feel well looked after in an agile environment? You have a proactive mindset and see great potential for your career in times of company growth and change?
If you are interested in experiencing this at a very well-positioned medium-sized and internationally operating pharmaceutical company, then you have come to the right place!
What will your activities as Regulatory Affairs Specialist CMC involve?
- Independent, self-driven planning, writing and compiling of CMC documents (in particular module 2.3 and 3) of assigned dossiers ensuring their compliance to regulatory requirements worldwide and according to agreed timelines
- Provide CMC support to development projects as well as for answering questions of health authorities
- Manage document lifecycle within the Regulatory Information Management System
- Ensure CMC documents are compliant at all times meeting GMP and other regulatory requirements
- Keeping abreast with changes to the regulatory landscape and requirements and communicate relevant changes to internal stakeholders
- Close cooperation and communication with other departments, consultants, CMOs as well as with affiliates, including pro-actively advising on potential regulatory risks and recommending compliant actions
- Forecast expected costs & required resources of CMC regulatory activities and adhere to the agreed budget
- Actively contribute to important department deliverables such as strategy development, compliance activities, improvement of intra- & interdepartmental collaboration, optimizing internal process & standards etc.
What does this position offer you?
- Salary: basic salary + 13th salary
- Contract type: unlimited
- Vacation: 30 days / year
- Working time: 40 hours / week
- Accessibility: Very good transport connections by public transport; sufficient parking spaces available
- Start date: At the next possible date
- Homeoffice: 2 days / week
What requirements should you bring along?
- University degree in pharmacy, (bio)chemistry or other life science; Master of Drug Regulatory Affairs is a plus
- At least 2 years of professional experience in Regulatory Affairs in the pharmaceutical industry with an emphasis to CMC activities
- Excellent knowledge of the technical & regulatory requirements (incl. pharmaceutical analytics, pharmaceutical technology, etc.) for dossiers of medicinal products around the globe (EU, ICH and others)
- Experience in working with regulatory information management systems & databases
- Accurate, analytical, independent, integrative and responsible working practices, value-oriented & entrepreneurial thinking and acting
- Demonstrated excellent organization and project management skills, ability to work in a team and to complete tasks in a detail-oriented manner with high standard despite tight deadlines
- Excellent English communication skills (both oral and written; German and further languages an advantage); able to communicate effectively to convey complex technical information to various internal stakeholders and to discuss/present expert matters confidently
Information about our customer:
Our client is an international pharmaceutical company with about 1000 employees in more than 30 countries. The company has been completely family-owned from the very beginning (founded in 1971) and develops and sells biofactor and generic products. The product range includes prescription drugs as well as OTC products and dietary supplements. As part of a large-scale growth initiative, the company plans to multiply its turnover in the coming years.
I look forward to your application!