Ort: Switzerland - Meyrin/Geneva
Funktion: Regulatory Affairs
Firma: OM Pharma
We are looking for a Regulatory Affairs Manager APAC for our biotech production site in Geneva. Reporting to the RA Regional Head/International, you are responsible for assigned regulatory projects related to the APAC region. Your main responsibilities are as follows:
- Create regulatory strategies based on the good knowledge and appropriate interpretation of guidelines, directives etc.
- Ensure successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the APAC region, especially China
- Act as a point of contact for all regulatory affairs matters concerning the APAC region
- Plan all regulatory activities with the assigned partner companies and ensure timely execution
- Communicate with internal stakeholders such as PV, Quality and other departments to ensure compliance and alignment with agreed partner support levels
- Improve business performance by shortening time to market and speed of product change implementation
- Work with the legal department on the regulatory review of existing and establishment of new license agreements
- Ensure the accuracy and completeness of assigned database entries according to internal guidelines
To carry out this mission, we are looking for a person with the following profile:
- Degree in the fields of Life Sciences (Master, Pharmacist or PhD)
- At least 5 years of experience in Regulatory Affairs related to APAC countries / China
- Ability to analyze the regulatory requirements (particularly APAC regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategies
- Fluent (written and spoken) in English and ideally Chinese (would be strongly valued), French is a plus
You describe yourself as an analytical and result-oriented 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 leadership, entrepreneurship 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.