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Manager CMC Regulatory Affairs (m/f/x)

  • Location: Münchendorf
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 18 days ago

  • Sector: Pharmaceutical
  • Contact: Sebastian Gotzler
  • Contact Email:
  • Start Date: ASAP
  • Expiry Date: 09 December 2021
  • Job Ref: RA_2021_31_1636467699

Manager CMC Regulatory Affairs (m/f/x) | Munich / remote | Pharma

The Manager RACMC supports the regulatory life cycle management and maintenance in company territories (EU and non-EU), provides regulatory guidance and strategy to assigned regulatory projects and approved products in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards, drug laws and regulations. This activity includes all quality aspects (Module 2 and 3) of the marketing authorization. In this role, the manager ensures maintenance of approved products, provides regulatory oversight and ensures regulatory compliance. The Manager RACMC communicates EU and international regulatory requirements to authoring teams and develops the regulatory strategies and collaborates companywide within the RACMC department and subject matter experts.

What will your tasks as "Manager CMC Regulatory Affairs (m/f/x)" be?

  • Represent EU RACMC in global regulatory, supply chain and development teams and provide regulatory guidance and strategy for assigned projects and products
  • Liaise, negotiate and communicate with functional groups, corporate partners, affiliates and agencies to obtain and/or provide information/data for regulatory submissions
  • Interpret, develop strategy and lead response preparation on Health Authority information requests
  • Lead preparation of Module 2.3 (Quality Overall Summary) and Module 3 CTD documents for development, EU MAAs and LCM filings to European and other assigned non-EU authorities
  • Provides operational regulatory support in document authoring, review and document management system
  • Develop regulatory strategies, provide risk assessments
  • Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders
  • Participate in or lead assigned non-project tasks designed to enhance the functionality and processes of RACMC

What does the position "Manager CMC Regulatory Affairs (m/f/x)" offer to you?

  • Type of contract: full time - limited for 3 years (possibility to go unlimited can be discussed)
  • Vacation: 30 days / year
  • Working hours: 40 hours / week
  • Salary: Basic salary + Bonus
  • Benefits: Opportunities for further qualification, a pleasant working atmosphere in a committed team, flat hierarchies and short decision-making paths, various internal and external catering options, options for childcare in the surrounding area, wide range of health and sports activities (e.g. company doctor); highly flexible working model; attractive remuneration and benefits offer
  • Accessibility: On-site parking and very good public transport connections
  • Start date: As soon as possible

Your requirements as a "Manager CMC Regulatory Affairs (m/f/x)"?

  • University degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus
  • Working experience in pharmaceutical industry, in CRO or in a regulatory authority with at least 2 years work experience in regulatory affairs with an emphasis on New Drug Applications or regulatory life cycle management activities in Europe (EU and non-EU) and international markets
  • Proven ability to plan, coordinate activities simultaneously on multiple projects
  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
  • Experience of working in global environment in interdisciplinary teams is a plus
  • Solution and detail-oriented; well organised and self-motivated
  • Excellent written and oral communication skills in English, German as a second language preferred
  • Strong working knowledge of Microsoft Office

Information about our client:

The company is one of the 20 largest pharmaceutical companies in the world and operates in 16 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thrombotic diseases and in the field of oncology.

Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!

I look forward to your application!