Careers

Regulatory Affairs CMC Manager

Job Description

JOB TITLE                                           Regulatory Affairs CMC Manager

REPORTING TO                                  VP CMC 

DEPARTMENT/FUNCTION               CMC

PLACE OF WORK                               Geneva, Switzerland

TYPE OF CONTRACT                        Permanent

 

The  Regulatory Affairs CMC Manager will interact globally with interdisciplinary project teams to provide strategic regulatory input to development, plan submission strategy and communicate submission documentation needed as well as timelines and strategic risks.


KEY TASKS & RESPONSIBILITIES

  • Plan, author and review CMC related submission documentation and provide input to and be accountable for the preparation of CMC dossiers for submission to Health Authorities for investigational and commercial products (e. g. IMPD, IND, responses to CMC; questions, MAA/NDA (and other territories when applies) Applications, post-approval variations, etc.). Plan, prepare, review CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings.
  • Identify potential CMC regulatory risks to the strategic / operational plans and propose options to mitigate risks.
  • Liaise with cross-functional CMC team members and external providers to ensure timely and effective regulatory submissions in support of drug pipeline progression.
  • Liaise with Regulatory Affairs team for regulatory strategy of development and commercial products.
  • Establish data requirements for CMC changes with CMC technical functions and Operations.
  • Follow new CMC activities from initial project plan, dossier preparation, support for registration and confirmation of revised status.
  • Advise/validate regulatory feasibility and strategy of proposed CMC modifications with CMC technical functions and Operations (Change control).
  • Reviews data provided to support updates/variations; prepares variation dossiers, supports registration and communicates final outcome Ensures all CMC dossiers are stored on the company’s IT drive and are kept current.


 PROFESSIONAL SKILLS & EXPERIENCE

  • Minimum of 5 years’ experience in Regulatory affairs with expertise in CMC
  • Significant CMC experience in small molecule development for human use
  • Successful experience in regulatory submissions and negotiations with regulatory bodies
  • Strong working knowledge of the EU and FDA CMC regulations
  • Ability to work under pressure and achieve timely submission and regulatory approvals
  • Excellent computer skills


PERSONAL SKILLS & COMPETENCIES

  • Working style driven by initiative, team focus, high flexibility and autonomy
  • Excellent planning, organisational and communication skills

 

 EDUCATION/LANGUAGES

  • M.S. or equivalent in chemistry, galenic, pharmacy or closely related field
  • Fluency in English is a must - mother tongue an asset.


Should your profile match the above requirements, and you are willing to join a passionate and committed team, please apply online using the following link: application Regulatory Affairs CMC Manager

We will only reply to applications in line with the above requirements.


In line with its culture, ObsEva is committed to ensuring full confidentiality in the treatment of all received data.