Position: Associate

Job type: Full-time

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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 (including early phase)
  • 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 8 years of experience in Pharmaceutical Industry and 5 years in regulatory affairs with proven expertise in CMC including in biotechnology
  • Experience in pharmaceutical development including clinical phase for original drug
  • Experience in CMC writing
  • Ideally, experience in development of products administered by nasal or/and pulmonary route, products issued from fermentation process and/or combination products
  • 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!

About Us

OM Pharma is a global Geneva-based biopharmaceutical 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 invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.

The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

For more information, visit the website: ompharma.com .
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Deadline: 04-05-2024

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