Senior Regulatory CMC Project Manager
Late-Stage Biotechnology Company
Remote | UK
Allerton Bishop is delighted to be partnering with an innovative late-stage biotechnology company to appoint a Senior Regulatory CMC Project Manager on 12 month contract
This is a rare opportunity to play a pivotal role in the development and registration of a novel therapy that is progressing through late stage clinical development and approaching global regulatory submission
Working directly with the Vice President of Regulatory Affairs and senior CMC leadership, the successful candidate will lead Regulatory CMC strategy, submission planning, and cross-functional programme execution to support NDA and MAA filings across major global market
s.This position offers significant visibility and influence within a highly collaborative biotechnology environment, providing the opportunity to contribute directly to the successful registration and commercialisation of a potentially transformative medicin
e.
The Opportun
ityAs Senior Regulatory CMC Project Manager, you will act as the critical interface between Regulatory Affairs, CMC Development, Technical Operations, Quality, Supply Chain, and external manufacturing partne
rs.
You will be responsible for driving CMC regulatory activities associated with late-stage development and commercial readiness, ensuring alignment between technical development programmes and global regulatory expectati
ons.A key focus of the role will be supporting the preparation, review, and authoring of CMC documentation required for NDA and MAA submissi
ons.
Key Responsibil
ities
Regulatory CMC Lead
* ershipLead Regulatory CMC activities supporting late phase development and registration str
* ategy.Develop and execute global CMC regulatory plans aligned to submission time
* lines.Act as the primary Regulatory CMC representative across cross-functional project
* teams.Provide strategic guidance on manufacturing changes, process validation, analytical methods, comparability, stability and lifecycle management activ
* ities.Assess regulatory risks associated with technical and operational deci
sions.
NDA & MAA Submission Act
* ivitiesLead preparation, review and authoring of Module 3 documentation for global submi
* ssions.Support NDA, MAA, IND, CTA and lifecycle management acti
* vities.Coordinate technical contributions from internal stakeholders, CDMOs and external consu
* ltants.Ensure consistency and compliance across all CMC submission documen
* responses to Health Authority questions and deficiency re
quests.
Global Regulatory
* StrategySupport interactions with FDA, EMA and other international regulatory auth
* orities.Provide guidance on evolving regulatory expectations and industry best p
* ractice.Partner with senior leadership to ensure regulatory strategies support accelerated development and commercial obj
* ectives.Contribute to inspection readiness and commercial launch planning act
ivities.
Programme L
* eadershipDrive complex cross-functional CMC deliverables and regulatory mi
* lestones.Coordinate internal and external stakeholders to ensure timely execution of submission ac
* tivities.Support programme governance, timeline management and critical path
* planning.Manage relationships with CDMOs, consultants and development
partners.
Candid
ate ProfileWe are seeking experienced Regulatory CMC professionals with proven expertise supporting late-stage development and commercial registration programmes. Successful candidates are likely to bring experience from biotechnology research, pharmaceutical manufacturers or regulatory c
onsultancy.
Essentia
* l ExperienceSignificant Regulatory CMC experience supporting small molecule pharmaceutic
* al products.Demonstrable experience authoring and reviewing Module 3 do
* involvement in NDA and/or MAA
* submissions.Experience supporting products through late phase development and registration
* activities.Strong understanding of global CMC regulatory requirements including FDA, EMA and I
* CH guidance.Experience leading or supporting successful ND
A approvals.
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