Senior CMC Regulatory Manager

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As Sr CMC Regulatory Manager at Symphogen, you will be a member of the Global Regulatory Team, where you will provide input to the regulatory strategy as well as work closely with CMC colleagues and perform regulatory evaluation and impact assessment of e.g. drug substance/drug product manufacturing process changes.

You will report directly to the Deputy Head of Regulatory CMC Department, and with a dotted reporting line to Director IND & Phase 1.

You will drive regulatory CMC activities during development and planned global submissions of MAAs, NDAs, and BLA, and be responsible for the quality documentation of their IND and CTA submissions as well as their Marketing Authorisation Applications (MAA) and life-cycle management for biologics.

Your main tasks are:

  • Lead and develop balances risk-based global regulatory CMC strategies for investigational and marketed products
  • Proactively contribute to and influence product development and life-cycle management
  • Effectively manage regulatory CMC aspects of projects including the preparation and submission of CMC sections of dossiers supporting CTAs, annual reports, and marketing authorization applications globally
  • Coordinate and contribute to the life-cycle management (variations in EU, CBE, PAS, renewal of application) at the international level (i.e. US, Europe, Japan, Canada, China, etc.)
  • Represent regulatory CMC in global cross-functional Operations teams including Manufacturing, Quality, CMC/MSAT, Supply Chain, Product Strategy
  • Lead the preparation of CMC response documents to Health Authority requests and Meeting Packages supporting Scientific Advice interactions
  • Ensure documents meet regulatory requirements, standards, and quality compliance
  • Stay up to date on US, EU, and International regulatory guidelines in specific areas

Specific quality/regulatory activities include:

  • Document, track, and follow up on CMC commitments
  • Regulatory review of Product Quality Review production
  • Contribute to Change Control procedures and evaluation: Regulatory impact analysis/assessment
  • Management regulatory aspects of Out Of Specification
  • Compliance with the Quality Manual and Quality System of the Company 

Your qualifications are a minimum of 5 years of relevant CMC/Regulatory CMC pharmaceutical industry experience. You possess strong regulatory strategy skills and an ability to thrive in a multi-faceted environment, and you are overall knowledgeable in ICH, FDA, and EMA guidelines and requirements. 

You have a Master’s Degree in Natural Science or a related field of study. 

You are a person with an open and problem-solving mindset, who has a pragmatic approach and can demonstrate critical thinking with attention to detail. You are fluent in English, and possess great communication skills, verbally as orally.

Symphogen offers a challenging and versatile job in an innovative, flexible, focused, and committed biotech environment. The environment is marked by strong cross-functional teamwork, with room for diversity, individual performance and development, and most important, passionate, and fun colleagues! As an employee in Symphogen, you will be part of a highly engaged and inspiring organization, and you will have the opportunity to influence job content and set your footprint on improving the lives of cancer patients.

Traveling: Approx. 10 days a year.

Domicile: In reasonable distance to the office in Ballerup.

For more details about the job or the company, please contact CEO, Jørn Duhn on M: +45 21 75 19 25, Client Manager, Gert Vium Andersen on M: +45 42 95 08 83, or Research Consultant, Emma Dahl on M: +45 51 43 43 17. All applications must be in English and are treated confidentially.

Company

Symphogen is a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology. We have a highly efficient antibody discovery and research platform supported by comprehensive early development capabilities.

Our antibody platform delivers antibodies with unique functionalities providing best or first in class potential as combination or mono therapy. Our approach and capabilities are well suited for combination therapies at the core of future cancer treatment.

Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 120 people

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