Regulatory Affairs Manager

10 Jul, 2022

Jobs

Regulatory Affairs Manager

Rentschler Biopharma
Milford, MA

Rentschler Biopharma, headquartered in Laupheim, Germany, is a leading contract development and manufacturing organization (CDMO), focused exclusively on client projects. Rentschler Biopharma offers process development and manufacturing of bio pharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler expanded its global footprint by opening a facility in the Boston metro area in Milford, MA. This site answers our US clients’ strong request to bring our expertise, innovation and state of the art, high-quality development, and manufacturing across the Atlantic to better serve the unique US market, a key market for Rentschler Biopharma. Milford’s proximity to our key US clients and Boston metro’s many biotech startups, large pharmaceutical companies, incubator sites, world-class universities and biotech-focused research institutions enable us to strengthen our important US partnerships and forge new ones, elevate our technological capabilities and tap into the region’s wide pool of expert talent

Job Summary

 

Provide Regulatory support for Rentschler Milford site. Work closely with Regulatory in Laupheim to support regulatory requirements.

 

Duties and Responsibilities

 

  • Regulatory assessment of all dossier-relevant project documents
  • Consulting customers and specialist departments (SMEs) on regulatory issues
  • Preparation and/or review of the regulatory dossiers for clinical trial /market supply
  • Dealing with questions from the authorities
  • Ensuring dossier compliance, as applicable
  • Planning and monitoring of quality strategies with regard to regulatory issues
  • Dealing with specific regulatory issues
  • Ensuring the creation of the product specification files (European clinical trials)

 

Qualifications

 

  • Completed studies in biology, chemistry, pharmacy, biotechnology, life science or other scientific studies with several years of professional experience in the biotechnological and regulatory environment.
  • PhD preferred.
  • Basic knowledge of the GMP environment
  • Several years of professional experience in a biotechnological and regulatory environment
  • Very good knowledge of written and spoken English
  • Good MS-Office skills
  • Analytical mindset
  • good team spirit
  • Organizational and communication skills

 

Working Conditions

 

Standard working conditions apply.  Ability to make decisions under pressure, ability to work with colleagues/senior managers/individual contributors.

Learn more here

Job posted: 2022-07-10