International Regulatory Affairs Manager

vor 2 Monaten

Berlin, Deutschland Avextra Pharma GmbH Vollzeit
Einleitung

Avextra is a German research-based biopharmaceutical company focused on developing life-changing, regulator approved medicines derived from the cannabis plant. Our product candidates have the potential to improve the quality of life for terminally ill patients and their loved ones.

Our people are the core of our business. Since our founding in 2019, we have built a uniquely talented international and interdisciplinary team based in Berlin, Bensheim (Hessen) and Portugal. Our journey has been propelled by a solid and dedicated investor base. We now seek to move our clinical development to the next level through a targeted and strategic expansion of that base.

Have you gathered your first experience with International Regulatory Affairs (perhaps even in the pharmaceutical industry ) and want to take your skills to the next level?

Are you a team player with in-depth understanding and experience of the EU regulatory requirements?

Then apply with us as International Regulatory Affairs Manager and become part of our team

We are looking for a candidate for a maternity leave absence. The International Regulatory Affairs Manager within Avextra Pharma GmbH is responsible for the compilation of regulatory documents for new products. To this end, the International Regulatory Affairs Manager collaborates on all measures necessary to obtain approval from international authorities for the development, manufacture, marketing, and distribution of the products. It is the responsibility of the International Regulatory Affairs Manager to demonstrate the safety, quality and efficacy of products to various international regulatory authorities and to demonstrate that international regulations, procedural guidelines and principles are being followed.

Tasks
  • Acquire comprehensive knowledge and understanding of regulatory affairs regulations, policies and procedures.
  • Ensure appropriate regulatory compliance.
  • Compile and maintain databases and systems for regulatory documentation.
  • Creation and revision of regulatory documents/CTD (Common Technical Document).
  • Support to external clients for the submission of product registration internationally.
  • Develop and update required documentation for clinical studies.
  • Support the submission for Clinical Studies and Marketing Authorizations.
  • Support and advise on regulatory processes and compliance issues.
  • Oversee the planning, coordination and management of regulatory documents.
  • Review, identify and interpretate relevant regulatory guidance, laws and regulations that have an impact on the company activities.
Requirements
  • University degree in natural sciences or comparable qualification.
  • +3 years of professional experience in the regulatory field (preferably within the pharmaceutical industry).
  • Knowledge of CTD preparation and maintenance.
  • Knowledge of CTIS management (preferably).
  • Ability to work to deadlines and successfully prioritize numerous projects simultaneously.
  • An in-depth understanding and experience of EU regulatory requirements including marketing authorization submissions and maintenance activities on a European level.
  • Ability to manage complex projects and timelines in a matrix team environment.
  • Very good written and spoken English skills.
  • Team spirit, communication and problem-solving skills, reliability, and an independent way of working.
Benefits

If you are interested in working with an innovative and dynamic company, Avextra is the perfect fit for you. We highly value the ideas, creativity and contributions of our colleagues and try hard to create a space where these can become part of our joint success. If new challenges motivate you and you enjoy your work, we would be delighted to receive your application and welcome you into our team.

At Avextra we are proud of our company culture and the values at its heart:

  • A solid development perspective and competitive compensation.
  • Flat heirarchies that offer equal opportunities for all colleagues to both shape and contribute to our pathway as a company.
  • A healthy corporate culture that integrates the diverse skills of a very special international team who work together in a spirit of mutual respect.
  • A structured onboarding process that allows employees to ease into existing team processes.
  • Opportunities for personal and professional growth and development.
  • A healthy, supportive and family-friendly workplace that appreciates work-life-balance.
  • Full time or no less than 30 hours per week.

We are looking for a candidate in the Bensheim area / or alternatively, Berlin area.



Avextra ist ein biopharmazeutisches Unternehmen mit Sitz im hessischen Bensheim. Unsere Wurzeln liegen in der deutschen Industrie für pflanzliche Arzneimittel. Wir glauben fest an das therapeutische Potenzial der Cannabispflanze.


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