Medior Technical Regulatory Writer (CMC)

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What we offer

Joining our consulting team means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

Job Description

The Technical Regulatory Writer is the key person in the submission of technical (quality) changes. He/she defines the strategy, prepares and coordinates the CMC submissions related the life cycle maintenance of Vaccines (CMC variations, commitments, market expansions, answers to questions from world-wide regulatory authorities). In overall, this person maintenains regulatory dossiers and interacts of course a lot with other regulatory teams (QC, QA, Production, Supply) to ensure File content definition. It is also a person who is at ease with the use of regulatory information management systems.

Key responsibilities of this role:

  • Under supervision of a CMC manager, liaise with contributing disciplines to define technical file content.
  • Ensure planning and proper organisation of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones.
  • Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/CMC and procedural sections) and ensure that those documents meet regulatory requirements. 
  • Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline, initiation and management of CMC submission kick-off meeting, file authoring, review and approval.
  • Provide support to the supervisor via critical review of the technical section of regulatory documents.
  • Ensure liaison with and in coordination between RA teams, RA management, Regulatory operations and any other stakeholders involved in the program.
  • Report significant issues to the management.

Profile

Experience/soft skills:

  • Experience of 3 to 5 years in CMC regulatory affairs / Technical Life Cycle Management, proven ability to manage typical regulatory activities, resolve problems and deliver results.
  • Experience in CMC authoring of CMC technical variations and Module 3 components.
  • Experience in Project Management.
  • Experience in change control process.
  • Experience working with Biologics.
  • Fluent in English (will be required to interact daily with teams based around the world).
  • Quality mindset, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
  • Manages own time to meet agreed short-term targets. 
  • Ability to clearly identify prioties and manage multiple tasks.
  • Good communication skills.
  • Analytical skills, creative and critical mind.
  • Team player.

Education:

  • Bachelor’s degree (Life Sciences background) or equivalent by experience. 

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Additional information

  • Remote status

    Temporarily remote

Or, know someone who would be a perfect fit? Let them know!

Waterloo

Drève Richelle 161
1410 Waterloo Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

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