Regulatory Affairs Head

icon building Company : Om Pharma
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Job Description - Regulatory Affairs Head

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. We are looking for a Regulatory Affairs Head - SRAs & Development based at our headquarter and production site in Geneva. Reporting to the Head of Regulatory Affairs and managing 5 people, your mission is to drive the Regulatory Affairs strategy and operations for what concerns development from early to late phase, expansion and lifecycle activities, at a global and regional scope in Stringent Regulatory Authority’s Countries. Your main responsibilities are as follows:

  • Lead the team and supervise Regulatory Affairs operations, in liaison with other Regulatory teams
  • Timely plan and follow activities for regulatory development such as scientific advices and meetings with HAs for clinical regulatory activities (CTA, IND, Protocol Amendments)
  • Review and ensure consistency of all scientific documentation from the development to the maintenance (Briefing books, IBs, Protocols, RMP, DSURS, BICs, CCDS, CTD sections etc.) according to internal procedures
  • Define and implement regulatory strategy particularly for the EU/CH region, for US and for any SRAs market such as China and Australia in liaison with other Regulatory teams
  • Budget and follow, from planning to execution, the activities of new registrations and maintenance of existing marketing authorizations: implement strategy and guidelines, set targets, manage Regulatory Affairs data, and assist the team for any issues they s may have
  • Coordinate the Change control regulatory assessment for labeling changes for EU/CH/SRAs and support the one for CMC changes.
  • Ensure compliance of the registered products to the legal requirements of the markets and to internal standards
  • Represent the Regulatory Affairs SRA’s and Development team in meetings internally and externally
  • Act as a business partner for the commercial organization and improve business performance by shortening time to market and speed of product change implementation
  • Liaise with Stringent Regulatory Authority (SRA), affiliates and local partners (distributors)
  • Work to increase the efficiency and effectiveness of the employees, processes, projects, and organizations as a whole and develop good regulatory practices
Business travels are required for this position, around 10% of working time. To carry out this mission, we are looking for a person with the following profile:
  • Degree in the field of Life Sciences (Master, Pharmacist or PhD), or equivalent educational background
  • At least 7-10 years of experience in Regulatory Affairs in the pharma industry
  • Strong understanding of Development activities from early phase I to late phase IV
  • Proven track record of successful meetings with HAs such as EMA, FDA, NMPA, BfArM, MHRA and/or TGA. Experience both at the global and the regional level (particularly EU and US)
  • Experience in direct people management
  • Full fluency in English with good professional skills in French
  • Proficiency in MS-Office tools
To be successful in this role, we are looking for a mature and reliable Regulatory Affairs leader with a good business acumen. You hold people management experience and truly enjoy coaching your teams to help them reaching success, fostering team spirit and proactivity. You describe yourself as solution oriented, flexible and able to take initiative to move things forward. Furthermore, your strategic thinking enables you to examine and understand issues from multiple points of view and work transversally with various internal and external stakeholders. If you are looking for a position in a smaller and dynamic pharmaceutical company where you can make the difference and leave your footprint, apply as soon as possible, and join OM Pharma!

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