Senior CMC Regulatory Lead (H/F)

Drive and perform regulatory CMC activities linked to product development, variations and submissions of MAAs/NDAs and expansion to the rest of the main international regulatory regions. As part of the Global regulatory CMC team, this position will define the CMC regulatory strategy in partnership with other Regulatory actors (eg Global Regulatory and affiliates). Moreover, they will be working in close collaboration with pharmaceutical development and industrial colleagues to provide regulatory impact assessments on tech transfer, scale-ups or method changes, for example. 
All these are in line with the enabling focus of RegCMC for development projects and products approvals.

Responsibilities :

• Lead and develop balanced risk-based global regulatory CMC strategies for different  investigational and marketed products.  Proactively contribute to and influence product development and life-cycle management.
• Effectively manage regulatory CMC aspects of projects including the preparation and submission of CMC sections of dossiers supporting clinical trial applications (i.e. IND/IMPD/CTA submissions), and annual reports submission , initial registration submission (e.g. submission to US, Europe, Japan, Canada, Brazil, EAEU, etc.) .  
• Coordinate and contribute to the life cycle management (variations in EU, CBE, PAS, renewal of application) at the international level (i.e. US, Europe, Japan, Canada etc.)

            Ensure monitoring of CMC commitments

• Ability to represent RegCMC in global cross-functional Operations teams including Manufacturing, Quality, CMC/MSAT, Supply Chain, Product Strategy
• Leads the preparation of CMC documents in response to Health Authority or Agency requests for information, meeting briefing books to support Scientific Advice interactions
• Manage pharmaceutical responsability activities 

       -    Management of Out Of Specification (OOS for batches under stability)
       -    Review of Product Quality Review (PQR) production and regulatory review of PQR
       -    Contribute to Change Control procedures and evaluation: Regulatory impact analysis
 

Profile :

• Relevant life-science degree: Master / PhD
• At least 10 years relevant CMC/Regulatory CMC pharmaceutical industry experience
• Prior direct, hands-on experience in the preparation and oversight of CMC submissions (INDs, IMPDs, NDA and/or MAAs, etc)
• Experience in supporting the delivery of marketing applications globally (i.e. specifically in the US and EU); experience in other markets (e.g. China, Eurasia, Brazil, etc.) is an advantage.
• Solid knowledge of module 3 (structure and content)
• Strong regulatory strategic skills and ability to be successful in a multi-faceted environment
• Knowledgeable in ICH, FDA and EMA guidelines and requirements
• Strong analytical skills
• Well organized, scientifically driven, pragmatic and open
• Comfortable with and capable of prioritizing multiple tasks, projects and objectives•    Excellent critical thinking and problem-solving skills
• Experience working collaboratively in multi-functional teams, network and alliance building
• Able to exercise discretion and confidentiality in a consistent and professional manner
• Strong verbal and written communication skills