Senior Director Regulatory Affairs (gn)

仕事内容

Your Responsibilities
The Senior Director Regulatory Affairs will develop and lead the global regulatory affairs strategy across all assets in the pipeline. The incumbent will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements. This person will also play a key role in Pieris’ strategic global development partners.

• Act as global regulatory lead in the indications Oncology and Respiratory diseases and define and execute corporate regulatory strategy
• Develop and implement a registration path for early-stage clinical development programs
• Provide regulatory strategy related to the documentation pertaining to non-clinical and clinical data prior to submission to HA
• Plan, prepare and conduct interactions with national authorities globally (EMA and FDA) in scope of product development
• Ensure adequate interaction with the project team members, in a matrix structure to solve regulatory problems/issues and to advance the project(s) through non-clinical and clinical development phases. Ensure transparent communication flow to all functions concerned in drug development relevant for his/her scope of duties
• Guide and influence colleagues in a matrix structure regarding the development and implementation of regulatory strategy through non-clinical, clinical and other processes
• Prepare, compile and review documents for regulatory submission, such as Clinical Trial Authorization (CTA) applications (initial and subsequent), Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs/BLAs), related supplements and amendments as well as clinical protocols
• Prepare and review study relevant documents, e.g. study protocol, Briefing Books, investigator’s brochure, IMPD, and ensure that they are compliant with regulatory requirements and regulations and the company’s QA (Quality Assurance) guidelines
• Set up, adjust and continuously optimize regulatory processes and interfaces (internal and external); supervise vendors and consultants in regulatory affairs on behalf of Pieris Pharmaceuticals
• Develop, implement, and review current policies and practices issued by Federal and international regulatory agencies
  

Our Requirements

• Bachelor’s degree or equivalent at minimum; Master’s degree or PhD preferred
• Longstanding related experience within the biotechnology/pharmaceutical industry with focus on the regulatory requirements for the drug development of Biologics/ Large Molecules
• Proven track record in regulatory strategy planning and proven ability to plan, coordinate and lead activities
• Knowledge of the relevant national and international regulations relating to the development and approval of biopharmaceuticals
• Prior experience with oncology products and/ or Respiratory products is preferred
• Ideally prior experience with regulatory support of clinical trials in EU and US and leading communications with the FDA and EMA
• Experience with programs leading to accelerated approval
• Successful completion of NDA, BLA and MAA application(s)
• Working knowledge of eCTD submissions and supportive technologies
• Ability to organize and carry out diverse activities in a changing environment often under time pressure
• Hands-On mentality and accountability to drive projects forward
  

Why us?
We are a fast-growing biotechnology company with about 150 employees in Hallbergmoos (Munich area) and Boston (USA). We are working in flat hierarchies with short decision-making processes and offer a working environment that is characterized by collaboration and innovation. Individual development is an important matter to us, which is why we offer tailor-made training programs.
In addition to a basic salary at a competitive level, our employees participate in an attractive bonus program based on the achievement of our corporate goals, as well as in our stock option program. In addition, we offer numerous special benefits, such as health insurance and a contribution to the company pension scheme. By providing a bright, friendly and state-of-the-art working environment in the Science/Innovations Hub with excellent technical equipment, state-of-the-art laboratories and a Pieris restaurant, we aim to foster a great on-site working environment.
A good work-life balance is very important to us at Pieris, so we make sure that family and well-being is a priority. We offer sufficient flexibility both in terms of working schedules and different lifestyles.
How To Reach Us
Hallbergmoos (Germany)
Zeppelinstraße 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0
Boston (USA)
Pieris Pharmaceuticals, Inc.
255 State Street, 9th floor
Boston, MA 02109
+1 (857) 246-8998
Note to Applicants: Pieris will always communicate with you from an @pieris.com email address and will never seek any financial information from you prior to an interview.
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About Us
Pieris Pharmaceuticals (Nasdaq: PIRS) is a clinical-stage biotechnology company with operations in Germany and the United States. Pieris discovers and develops Anticalin protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. It is our mission to develop life-changing therapeutic proteins for patients suffering from cancer and respiratory diseases through the innovative application of novel science and cutting-edge technologies.