VCLS

Role Description We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology and pharmaceutical clients developing innovative and complex therapies. The successful candidate will serve as a trusted strategic advisor to clients pursuing late-stage development and commercialization of complex biologics, such as combination products, with a particular emphasis on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role requires strong client-facing skills, business acumen, and the ability to contribute to the growth of a boutique consultancy through thought leadership, client development, and industry engagement. Qualifications - Degree in a life sciences discipline - Significant industry experience - Deep expertise in US FDA regulatory strategy for biologics - Multiple successful BLA experiences with direct FDA interactions - Significant experience with complex modalities, such as combination products and cell and gene therapies - Strong consulting, leadership, communication, and presentation skills Requirements - 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 - Experience with EMA and other international health authorities is highly valued - 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 Company Description

Role Description We are seeking an experienced and strategic Head of Chemistry, Manufacturing, and Controls (CMC) to lead the development and execution of global CMC strategy across a diverse therapeutic portfolio. This individual will provide technical and organizational leadership for biologics, combination products, oligonucleotides, and cell and gene therapy programs, spanning early development through late-stage development and commercialization readiness. The successful candidate will combine deep drug development expertise, strong cross-functional leadership, and proven experience building, managing, and developing teams. Consulting experience is a plus. Key Responsibilities - Define and lead phase-appropriate global CMC strategies across modalities for a diverse range of global clients - Provide thought leadership to raise the VCLS profile, including speaking at conferences, presenting webinars, and meeting VCLS clients Technical Oversight - Enable our clients’ development of biologics, oligonucleotides, combination products, and cell & gene therapies - Guide scalable manufacturing and analytical strategies - Write and review technical documentation, and provide input and support for CMC team members Regulatory Leadership - Oversee IND, CTA, BLA, NDA, MAA, and IMPD CMC documentation - Represent CMC in health authority interactions Vendor Management - Manage external partners, including external auditing and consulting partners - Drive performance and issue resolution People Leadership - Lead and develop a team of 5–10 staff - Build a high-performing and collaborative culture Cross-functional Collaboration - Partner with Regulatory, non-clinical, clinical, and business development teams to bring phase-appropriate solutions to VCLS clients and build the VCLS business Qualifications - Degree in a relevant scientific discipline - Significant industry experience in CMC and drug development - Expertise across biologics, oligonucleotides, combination products, and cell & gene therapies - Experience managing mid to large teams - Strong regulatory submission experience (US and/or UK/EU) - Knowledge of GMP and global regulatory requirements - Experience with CDMOs

Role Description This role exists because we believe excellence in proposals is a competitive advantage — and because the future of this work will be smarter, more automated, and more human, not less. As such, experience with Regulatory Proposals is essential. You will sit at the intersection of sales, science, and delivery helping ensure that: - Proposals are customized, accurate, compliant with the request, and compelling. - Proposals include real added value thanks to a holistic and scientific approach. You will work closely with an experienced Life Sciences Proposals Director known for authentic, supportive leadership. If you understand that a great proposal is both craft and a tool of persuasion, this role was designed with you in mind. What You’ll Do - Proposal Delivery & Quality - Lead the end-to-end coordination process of RFPs, RFIs, contracts, and change orders. - Liaise and coordinate with key operational managers, sales managers, and functional group leaders regarding the implementation strategy for the proposed project. - Develop customized drafts of proposals and budgets using existing templates. - Collaborate with strategic partners to complete the proposed offer. - Maintain and refine templates, boilerplate content, and modular sections. - Ensure proposals consistently reflect VCLS brand, tone, and quality standards. - Manage schedules, revisions, version control, and final submissions. - Provide solutions or ideas to improve the quality of the proposal. - Library, Automation & AI Enablement - Help implement and maintain proposal automation tools. - Manage content libraries and knowledge repositories to drive reuse and consistency. - Stay curious about emerging tools and share practical ideas that actually work. - Balance innovation with governance, compliance, and quality. - Cross-Functional Collaboration - Work seamlessly with Business Development and technical experts. - Ensure proposal data aligns with CRM and document management systems. - Act as “right-hand man” to the proposal director. - Mentor and train future newcomers to the team. Qualifications - Experience in proposal and budget development within Life Sciences or CROs. - A clear understanding of the different phases of pharmaceutical product development. - Exceptional attention to detail and comfort with structured, complex documents. - A collaborative mindset and confidence working across functions. - A genuine interest in automation, AI, and process improvement — whether expert or emerging. - The judgment to balance innovation with consistency and compliance. Requirements - Experience of regulatory activities is essential. - You take pride in getting the details right — and you see structure as a strength, not a constraint. - You understand that proposals are operationally demanding, strategically critical, and constantly evolving.