Voisin Consulting Life Sciences (VCLS)

Compliance

• Lead development and execution of US and global regulatory strategy for clients across all stages of development, with emphasis on late-stage development, registration, and lifecycle management.
• Serve as regulatory lead for ADCs, bispecific/trispecific antibodies, combination products, and other complex biologics.
• Provide guidance on BLA strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and post-approval strategy.
• Lead all aspects of health authority interactions.
• Support regulatory due diligence activities.
• Serve as a senior strategic advisor and primary client contact.
• Build long-term biotech and pharmaceutical client relationships.
• Lead multidisciplinary consulting teams and mentor junior staff.
• Deliver high-quality regulatory recommendations, reports, and presentations.
• Support business development, proposals, and client pitches.
• Represent the organization at conferences and industry events.
• Develop thought leadership materials and support company growth.

Senior Director – US Regulatory Strategy

General

• Format regulatory documents according to company and regulatory agency standards
• Create and maintain document templates, style guides and formatting standards
• Create and maintain submission-ready PDFs including Bookmarks, Hyperlinks, Table of Contents, page numbering, metadata etc.
• Perform quality control (QC) reviews of regulatory documents before publishing and submission.
• Ensure compliance with CTD/eCTD, NeeS, and eDok formatting requirements.
• Support preparation of dossiers for submissions to agencies such as US FDA, EMA, MHRA, Swissmedic and Health Canada
• Manage document life cycle activities, version control and archival
• Coordinate with Regulatory affairs, medical writing, CMC, Clinical and Quality teams to obtain and process submission documents
• Support Publishing teams during dossier compilation and submission activities
• Maintain submission trackers, regulatory archives and document repositories
• Monitor evolving regulatory submission standards and provide guidance to stakeholders
• Participate in the update of internal eCTD Distinct Technical Procedures (DTPs)
• Provide training and mentoring to document/eCTD Specialists (when applicable)
• Interact frequently with clients during project execution and discuss/challenge as necessary
• Proactively communicate with colleagues at all levels to ensure mutual exchange of information
• Collaborate with all regulatory teams to ensure good coordination of activities and a coherent clinical program
• Liaise with sponsor, regulatory authorities and/or service providers when appropriate
• Raise awareness of potential opportunities regarding transversal activities (eg. for other Service Units and/or Areas of Expertise and/or Geographical Areas)
• Proactively contribute to knowledge sharing within VCLS

Document Specialist

Business Development Rep

• Identify and pursue new business opportunities within the Life Sciences industry to achieve sales and profitability targets.
• Develop and nurture strong relationships with clients, partners, and key stakeholders to enhance client retention and satisfaction.
• Collaborate across departments including marketing, service delivery, and leadership to align business development goals with overall company strategy.
• Lead the preparation and presentation of business proposals, negotiations, and contract management.
• Represent VCLS at industry conferences, networking events, and other platforms to promote company services and expand professional networks.
• Provide market insights and gather competitive intelligence to inform strategic business decisions.

Senior Director – US Regulatory Strategy

Document Specialist

Director, Business Development