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Senior CMC Regulatory Manager

Are you experienced in Regulatory CMC and are you able to drive and develop regulatory strategies for CMC activities? Then Symphogen is looking for you as their next member of the Global Regulatory Team!

 

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 balanced 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.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
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