Head of Regulatory Affairs

  • Pieris Pharmaceuticals GmbH
  • Pieris Pharmaceuticals, Inc.
  • Fulltime
  • Published: 05.05.2021
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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.




 

Your Tasks

The Head of Regulatory Affairs will develop and lead the global regulatory affairs strategy across all assets, with an immediate focus in oncology/immuno- oncology. 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.
  • Play a key role in developing and implementing corporate regulatory strategy to ensure competitive advantage
  • Develop content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs/BLAs), related supplements and amendments as well as clinical protocols
  • Lead communications with external regulatory consultants on a project basis
  • Develop and implement a registration path for early clinical development stage programs
  • Advise and oversee internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes
  • Oversee preparation, submission, application, and routine reports, including preparation of amendments and supplements, as required by internal departments
  • Develop and maintain excellent relationships with regulatory agency personnel. Respond to requests for additional data and organize and manage participation in meetings. Negotiate directly with regulatory authorities regarding company’s filings.
  • Develop, implement, and review current policies and practices issued by Federal and international regulatory agencies.

Our Requirements

  • Bachelor degree or equivalent at minimum; Master’s degree or PhD preferred.
  • Longstanding related experience within the biotechnology/pharmaceutical industry along with significant clinical regulatory experience.
  • Prior experience with oncology products is highly preferred. Respiratory experience is preferred.
  • Required: Prior experience leading communications with the FDA.
  • Experience with programs leading to accelerated approval.
  • Successful completion of NDA and MAA application(s).
  • Working knowledge of eCTD submissions and supportive technologies.

Pieris is a fast-growing biotechnology company with approximately 130 employees across our sites in Munich, Germany and Boston, United States. We work in flat hierarchies with short decision-making paths and offer a working environment characterized by cooperation and innovation. Each of our employees participates in a bonus program based on the achievement of our company goals. In addition, we offer each employee the opportunity to participate in a stock purchase plan as well as a stock option program that allows Pieris employees to benefit directly from the our success.
 
Numerous social benefits such as an additional employer-financed company health insurance, free drinks etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in both of our locations round off our overall package. Creative employee events take place several times a year, as we believe that a healthy spirit of collaboration is key to our success.
 

Equal Opportunity Employer Statement

Pieris provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Pieris complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

 

How to reach us

Zeppelinstraße 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0

Pieris Pharmaceuticals, Inc.
255 State Street, 9th floor
Boston, MA 02109
USA
+1 (857) 246-8998