Proclinical is seeking a dedicated and scientifically adept individual to provide analytical strategic and scientific expertise in support of submissions to Regulatory authorities. The role involves overseeing and responding to questions from regulatory authorities related to method performance, validation, transfer, stability, release specifications, and interpretation of comparability and similarity data. The successful candidate will also be responsible for authoring, reviewing, and validating analytical CMC sections of dossiers delivered to regulatory agencies, ensuring compliance and data integrity.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Provide analytical expertise in the field of mAbs/protein analytics to deliver industry-leading analytical packages.
- Collaborate with CMC Development teams, Regulatory Affairs, and Quality functions to deliver analytical packages against project objectives.
- Write and review analytical relevant sections of Health Authority submissions.
- Drive best practice to ensure efficient and timely response to regulatory questions.
- Liaise with functional heads and Regulatory CMC to develop a portfolio of topic-specific templates.
- Manage direct/indirect interaction with Analytical Teams in support of Phase III development, Biosimilar license application, and post-marketing support.
- Develop risk management strategies for product lifecycle maintenance.
- Interface with external CROs, CMOs, and licensing partners to set expectations, define work packages, measure progress and delivery.
- Represent the company at regulatory authority meetings and at internal review committees.
Key Skills and Requirements:
- Advanced scientific degree in biochemistry, bioanalytics, or related fields. Further qualifications such as MSc, PhD, or specific vocational training would be advantageous.
- Fluency in English, both oral and written; additional languages (German or French) are an asset.
- Minimum of 7 years experience in R&D in the biopharma/biotech industry specializing in mAbs/protein analytics.
- Sound knowledge in GLP/GMP, ability to interpret guidelines and to implement compliant analytical packages in highly regulated markets.
- Proven experience representing analytical development in regulatory consultations for biosimilar products.
- Excellent analytical and organizational skills.
- Leadership competencies (proactive problem solving, influencing, and decision making).
- Excellent communication skills, both oral and written with demonstrated ability to summarize analytical studies from reports and presentations.
- Strong interpersonal, networking, and relationship skills required, including teamwork and listening skills.
If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh on r.saleh@proclinical.com.
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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