Position: Associate

Job type: Full-time

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Job content

Your Main Responsibilities Are As Follows

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.
  • 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!

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.

In October 2020, Etienne Jornod, former Executive Chairman of Vifor Pharma and Galenica, acquired the company together with entrepreneurs and strategic partner, Abdi Ibrahim, with the ambition to continue its global expansion and to invest CHF 250 million in R&D and manufacturing capacity expansion.

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, visitthe website: ompharma.com .
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Deadline: 13-05-2024

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