Agiana Pharma is looking for Director Regulatory Affairs & Quality Assurance

Agiana Pharma

There is a great unmet need for a new anti-arrhythmic drug in patients with heart failure. Agiana Pharma, a Norwegian based pharmaceutical company founded in 2021, is developing the first new class of anti-arrhythmic therapy in 50 years. Our lead candidate AGP 100 is targeting a large patient population with a great unmet need. AGP 100 is protected by a strong IP portfolio and supported by extensive pre-clinical and clinical phase I data, with evidence of an excellent tolerability and safety profile. With a strong Board of Directors and Scientific Advisory Board, we are now heading for Phase IIa proof of concept study.

To enter the next step in the journey of developing a new, first-in-class anti-arrhythmic therapy, we are looking for a

Director Regulatory Affairs & Quality Assurance

We are about to start a phase IIa proof of concept trial with our lead candidate AGP 100. Our new Director Regulatory Affairs & Quality Assurance will be responsible for the overall regulatory strategy, building the documentation file and continuously improving Quality System processes required by international, regional and national regulatory authorities and standards.

 

Main areas of responsibility:

  • global regulatory strategy: proactively develop and provide regulatory guidance and strategies for optimal drug development and marketing authorizations globally. Collaborate with cross functional peers to facilitate and optimize the product development and registration process
  • ensuring compilation and filing of relevant regulatory applications
  • collaborating with the Clinical Operations team and clinical CROs on compilation of clinical trial applications
  • ensure high quality documentation in regulatory submissions such as clinical trial applications, CTA/IND submissions, and meeting briefing packages and effectively manage associated timelines. 
  • ensuring timely follow-up on Health Authority requests and commitments
  • establishing approved documents, maintain and continuously improve Quality System processes required by international, regional and national regulatory authorities and standards
  • build, manage, motivate, and keep accountable a world-class team to execute on the company’s quality and regulatory strategy
  • ensuring that relevant SOPs are in compliance with regulatory requirements and standards

This is an exciting opportunity to develop the regulatory and quality organization and be part of Agiana Pharma´s management team where you will be involved in both executing the strategy and company development.

We offer a high-impact role and a key position in the company.

The position will be based at Agiana Pharma´s Head Quarter in Oslo and reports to the CEO.


Preferred profile:

You have previous experience in Regulatory Affairs and Quality Assurance within the Pharmaceutical industry and profound understanding of regulatory requirements, with focus on regulations and guidance documents. 

The ideal candidate will be a highly motivated individual with experience from and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

We prefer residency in Norway. The position will be based at Agiana Pharma´s Head Quarter in Oslo and reports to the CEO.

 

Eager to learn more?

This recruitment is carried out in collaboration with the executive search firm Borka Consulting AS.
Borka Consulting specializes in finding talented candidates in all roles in the Life Science sector in Norway, The Nordics and in Europe.

If you have any questions regarding Agiana Pharma or the position, feel free to contact our recruitment advisor in Borka Consulting; André Borka at +47 908 31 871.

Please send your application (both motivational letter and CV in PDF format) to andre@borka.no.

All inquiries are treated confidentially, also towards Agiana Pharma in the initial phase if desired. We evaluate applications continuously and look forward to receiving your application.

 

For å søke på denne stillingen må du sende en e-post med CV og søknadsbrev til andre@borka.no

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