Director - Cmc Regulatory Affairs (M/F/d)

vor 2 Wochen

Wien, Österreich HOOKIPA Biotech GmbH Vollzeit

**About HOOKIPA**:
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer.

This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel immunotherapies induce robust antigen-specific killer T cells to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. HOOKIPA’s platform technology uses replicating viral vectors based on the target cancer, with the potential to induce killer T cell response levels previously not achieved by other immunotherapy approaches.

HOOKIPA’s pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed projects. In addition, the company aims to develop functional cures of HBV and HIV in collaboration with Gilead.

**Position Summary**:
The Regulatory Affairs Director is a creative, resourceful, integrative thinker that is responsible for key regulatory CMC activities supporting the development and commercialization of Hookipa's products, with a focus on developing and implementing regulatory strategies as well as coordinating and responding to questions from Health Authorities. Responsibilities will include development and implementation of CMC strategy from early development to post product approval, preparation, and review of CTD Module 3, QOS, and other documents for FDA/EMA submission, assistance with preparation for FDA meetings, regulatory review of cGMP documentation, and general regulatory compliance activities.

**Main Responsibilities**:

- Serve as the Regulatory Affairs (RA) CMC project representative to the Regulatory Development team, covering US, EU, and the rest of the world CMC regulatory requirements for regulatory submissions from early development to post-commercial maintenance of assigned products and dossiers
- Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
- Manage regulatory submissions that involve CMC components including CBEs/PASs/ CTAs/INDs/NDAs and agency meeting packages
- Contribute to the preparation of meetings with regulatory agencies
- Support Health Authority interactions and negotiations including more complex interactions for all CMC topics for assigned Hookipa projects, setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
- Drive follow-up action plans resulting from agency feedback for assigned Hookipa projects.
- Participate in negotiations with regulatory agencies to resolve CMC and GMO issues
- Assist during regulatory agency inspections
- Actively participate in RA infrastructure and capability building
- Proactively support activities in design of global regulatory strategies for the development of therapeutic oncology and infectious disease products
- Available to travel (approximately 1 week per 2-4 months)

**Qualifications**:

- BS in life science related field required, MS/PhD preferred
- Oncology, Vaccine or Biologics experience preferred
- Minimum 6 years of experience in the pharmaceutical/biotechnology/life science industry. 4+ years regulatory affairs experience including regulatory CMC and/or GMO strategy for development and/or commercial pharmaceutical products required
- Experience with cell and gene therapy and vaccines are a plus
- Experience of working in a global, matrix environment (multidisciplinary international team).
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts within the company and with alliance partners
- Excellent written and oral English, communication skills, and attention to detail
- Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines
- Understanding of electronic submissions
- Knowledge and understanding of US, EU, Canada, and ICH guidelines. Understanding of international GMO requirements is a plus
- Highly computer literate (MS Office suite, WebEx and secure file sharing )

**What we offer**:

- Strong and highly motivated team
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment
- Employee benefits such as health screening, public transportation card, Sodexo pass

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 5.438, - based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

Starting date: as so

  • Director - Cmc Regulatory Affairs (M/F/d)

    vor 1 Woche

    Wien, Wien, Österreich HOOKIPA Biotech GmbH Vollzeit

    About HOOKIPA:HOOKIPA Pharma Inc (NASDAQ:HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer.This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel...

  • Senior Manager, Global Regulatory Affairs Cmc

    vor 1 Woche

    Wien, Wien, Österreich Takeda Pharmaceutical Vollzeit

    About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as...

  • Director Global Regulatory Affairs

    Vor 2 Tagen

    Wien, Österreich Talentor Sweden AB Vollzeit

    **Director Global Regulatory Affairs (f/m/x)**: **PhD and HQ-Can do-experience are requested**: ***YOUR FUTURE ROLE**: - Lead, improve and redefine regulatory strategy and activities for all areas of product development (pre-clinical, CMC and manufacturing and clinical) - Drive in cross-functional execution and alignment - Establish and execute all...

  • Director Global Regulatory Affairs

    vor 2 Monaten

    Wien, Wien, Österreich Talentor Austria Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 3 Wochen

    Wien, Wien, Österreich Talentor Austria Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 1 Woche

    Wien, Wien, Österreich Talentor Austria GmbH Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 1 Monat

    Wien, Österreich Talentor Austria GmbH Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 1 Monat

    Wien, Österreich Talentor Austria GmbH Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 2 Monaten

    Wien, Österreich Talentor Austria GmbH Vollzeit

     Are you ready for the next step in your career? Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 2 Monaten

    Wien, Österreich Talentor Austria GmbH Vollzeit

     Are you ready for the next step in your career? Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 3 Wochen

    Wien, Österreich Talentor Austria GmbH Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 3 Wochen

    Wien, Österreich Talentor Austria GmbH Vollzeit

     Are you ready for the next step in your career? Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 3 Wochen

    Wien, Österreich Talentor Austria GmbH Vollzeit

     Are you ready for the next step in your career? Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Regulatory Affairs

    vor 3 Wochen

    Wien, Österreich Talentor Austria GmbH Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Manufacturing and CMC

    vor 2 Monaten

    Wien, Wien, Österreich Talentor Austria Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Manufacturing and CMC

    vor 3 Wochen

    Wien, Wien, Österreich Talentor Austria Vollzeit

    Are you ready for the next step in your career?Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell...

  • Director Global Manufacturing and CMC

    vor 4 Wochen

    Wien, Österreich Talentor Austria GmbH Vollzeit

    Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell carcinoma. Our client's aim is to bring the first in...

  • Director Global Manufacturing and CMC

    vor 2 Monaten

    Wien, Österreich Talentor Austria GmbH Vollzeit

    Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell carcinoma. Our client's aim is to bring the first in...

  • Director Global Manufacturing and CMC

    vor 3 Wochen

    Wien, Österreich Talentor Austria GmbH Vollzeit

    Our client is a Swiss biotech company with currently setting up headquarters in Vienna and a focus on the development of patient-individualized treatments for chronic and malignant diseases. The lead candidate under development is an autologous cancer vaccine, initially explored in the adjuvant renal cell carcinoma. Our client's aim is to bring the first in...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Wien, Österreich Boehringer Ingelheim Vollzeit

    **Regulatory Affairs Manager (w/m/d)** **-** **230926** **DIE STELLE** Wir suchen ab sofort eine/n Regulatory Affairs ManagerIn, die/der mit hohem Verantwortungsbewusstsein eine abwechslungsreiche Tätigkeit für globale Zulassungsprojekte im Bereich der Biopharmazie übernimmt. **Aufgaben und Zuständigkeiten** - Laterale Leitung von...