Director (m/f/d), Regulatory Affairs, CMC

  • Boston
  • Hallbergmoos
  • Research, development, teaching
  • Fulltime
  • Published: 25.08.2020

Pieris Pharmaceuticals (Nasdaq: PIRS) is a publicly-traded, clinical-stage biotechnology company with operations in Germany and the United States. Pieris specializes in the discovery and development of 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, immuno-oncology multi-specifics tailored for the tumor microenvironment, and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.

Your Tasks

  • The successful candidate will be responsible for formulating and implementing CMC regulatory strategies, submissions and compliance activities required to achieve regulatory approvals, building out the Regulatory CMC organization, and collaborating with internal and external stakeholders to advance Pieris’ proprietary Anticalin® pipeline on global project teams. This leadership role will possess a deep knowledge, understanding, interpretation and utilization of regulatory guidances and regulations focused on biologics (specifically therapeutic protein products), as well as industry standards and best practices.
  • Proactively manages regulatory CMC aspects of programs including overseeing preparation and submission of CMC submissions supporting clinical trial applications and marketing applications appropriate to phase of development. Writing regulatory documents and acting as in-house expert to internal and external parties.
  • Ensures timely delivery of high-quality CMC documents including, regulatory authority requests for information, meeting briefing books, meeting minutes, IND/IMPD /CTA submissions, NOA/MAA submissions, and DMFs while assuring all documents meet regulatory requirements and quality compliance.
  • Supports and complies with procedures for electronic submissions and document archiving to ensure efficiency and traceability of all CMC regulatory documents.
  • Facilitates the development of, reviews and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development.
  • Articulates complex Regulatory CMC issues to project teams and external stakeholders to support global development of drug candidates.
  • Evaluates proposed manufacturing and quality changes for impact to ongoing and existing filings and provides strategic regulatory guidance for optimal implementation of changes.
  • Manages interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments /supplements/variations, and other submissions which present CMC information.
  • Develops and maintains excellent relationships with regulatory authorities, internal functional groups especially CMC colleagues, contract manufacturing organizations, and corporate partners.
  • Supports Quality Assurance in preparing and hosting regulatory inspections.
  • Maintains in-depth and current understanding of the laws, regulations and guidelines pertaining to CMC/Quality information relevant to Pieris’ development programs
  • Supports Head of RA in the development of overall product development and registration strategy and aligns regulatory CMC activities with overall CMC strategy as elucidated by CSO/Head of CMC

Our Requirements

  • BS or MSc in a scientific discipline, a combination of relevant education and applicable job experience may be considered.
  • 5-10+ years of CMC regulatory experience within a biotech/pharmaceutical environment working on biologics (preferably therapeutic proteins) plus recognized technical expert
  • Demonstrated ability to deliver high quality regulatory documents including the preparation of Module 3 and CMC amendments; direct experience interacting with regulatory authorities is preferred
  • Ability to interpret compliance requirements for the creation or review of protocols and site documentation
  • Must be a leader capable both of working independently in a fast-paced environment and also as a key member of global project teams

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.
 

How to reach us

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

255 State Street, 9th floor
Boston, MA 02109 / USA
+1 (857) 246-8998