Ort: Switzerland - Meyrin/Geneva
Funktion: Regulatory Affairs
Firma: OM Pharma
In view of our continued global growth, we are looking for further support and recruiting a Regulatory Affairs CMC Manager at our biotech production site in Geneva. In this position you report to the CMC Team Lead and your mission is to coordinate CMC activities for assigned products. Your main responsibilities are as follows:
- Identify required content to ensure compliance with regulatory standards and review CMC documents from technical departments
- Author high-quality CMC documents in the frame of renewals, variations, life cycle management activities and new registration
- Manage answers to questions from Health Authorities related to CMC topics
- Liaise with Therapeutic Areas, International, Submission and Regulatory Operations groups to ensure appropriate planning and timely preparation of CMC-related submissions
- Coordinate assessment of worldwide impact of proposed changes, ensure the regulatory implications have been considered and provide regulatory strategy for optimal and timely implementation of these changes
- Participate and represent Regulatory CMC in cross-departmental project teams
- Provide input as a technical expert on questions concerning CMC/Module 3 documentation and regulations
- Provide required support to audits/inspections from partners and Health Authorities
- Ensure alignment with Global CMC team and contribute to the improvement of departmental and cross-functional processes
- Provide guidance and mentor junior staff
To carry out this mission, we are looking for a person with the following profile:
- Academic degree in the fields of natural science
- At least 6 years of experience in Pharmaceutical Industry and 4 years in regulatory affairs with proven expertise in CMC including in biotechnology
- Experience in CMC writing
- Ideally, experience in products issued from fermentation process
- Ideally, experience with registration in United States territories (FDA) for biological products and experience in pharmaceutical development including clinical phase for original drug
- Experience with quality management processes and Good Manufacturing Practices
- Fluent in English and French
You describe yourself as a solution oriented and flexible person who enjoys working in a dynamic environment. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines. You also demonstrate strong adaptability, communication and negotiation skills, and you like to interact with various stakeholders.
Are you interested in this opportunity? Apply now and join OM Pharma!
OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.