Format regulatory documents according to company and regulatory agency standardsCreate and maintain document templates, style guides and formatting standardsCreate and maintain submission-ready PDFs including Bookmarks, …
Skills: Regulatory Document Formatting, eCTD, NeeS, eDok, Microsoft Word
Director, Business Development VCLS is looking for an experienced and strategic Director, Business Development to join our team and lead initiatives that drive business growth and client acquisition in the Life Sciences …
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Full-time
bachelor degree
Posted 4d ago
~40 hrs/week
Responsibilities
Responsible for formatting and quality controlling regulatory documents to ensure compliance with agency standards for submissions to the FDA, EMA, and other authorities. Manages the document life cycle, maintains templates, and coordinates with cross-functional teams to compile submission dossiers.
Requirements
Requires a degree in Life Sciences and proven experience in regulatory publishing or document formatting, specifically with eCTD, NeeS, or eDok. Must possess strong Microsoft Word skills and the ability to work under tight deadlines in a quality-controlled environment.
Full job description
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
Life Science Graduate + solid academic background in Life Sciences;
Proven experience in document formatting, regulatory publishing or operations
Experience supporting eCTD, NeeS or eDok submissions
Knowledge of document management systems and quality-controlled environments
Strong knowledge of Microsoft word formatting
Experience in a consulting environment is a plus;
Good command of MS Office (Word, Excel, PowerPoint);
Excellent attention to detail and organizational skills
Strong problem-solving skills, ability to work under tight deadlines and manage multiple projects
Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
Global reference partner to expedite access of HealthTech products to regulated markets.
Industry
Biotechnology Research
Company size
201-500 employees
Founded
1997
Headquarters
Paris, Paris
LinkedIn followers
39,570
From discovery to product launch and lifecycle management
At VCLS (Voisin Consulting Life Sciences), regulatory science guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Starting early in the process, from discovery to the patient, VCLS assists innovators in designing optimized product development plans and regulatory strategies, combining the health ecosystem with commercial success. With a presence in seven locations across three continents and over 200 employees, VCLS serves a broad range of healthtech developers and their investors.
Together, we accompany global stakeholders to expedite HealthTech products from discovery to patient access and beyond by bridging Science to Regulatory and Market Access strategies.
Offices: 64, Avenue Pierre Grenier, Boulogne, Paris, Paris 92100, FR · EPFL Innovation Park, Lausanne, Health Valley 1015, CH · St John’s Innovation Centre, Cowley Road, Cambridge, CB4 0WS, GB · 1 Broadway, 14th Floor, Cambridge, Massachusetts 02142, US · Axis Praha, sy no. 20/4, East Wing, 4th floor, Ranka Colony Rd, Munivenkatappa Layout, Bangalore, Karnataka 560076, IN
Orphan DrugsBiologicsMedical DevicesClinical / Non ClinicalSafety & VigilanceMarket Accesspricing & reimbursementLife Cycle ManagementCMC (ChemistryManufacturing and Control)
Global reference partner to expedite access of HealthTech products to regulated markets.
Industry
Biotechnology Research
Company size
201-500 employees
Founded
1997
Headquarters
Paris, Paris
LinkedIn followers
39,570
From discovery to product launch and lifecycle management
At VCLS (Voisin Consulting Life Sciences), regulatory science guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Starting early in the process, from discovery to the patient, VCLS assists innovators in designing optimized product development plans and regulatory strategies, combining the health ecosystem with commercial success. With a presence in seven locations across three continents and over 200 employees, VCLS serves a broad range of healthtech developers and their investors.
Together, we accompany global stakeholders to expedite HealthTech products from discovery to patient access and beyond by bridging Science to Regulatory and Market Access strategies.
Offices: 64, Avenue Pierre Grenier, Boulogne, Paris, Paris 92100, FR · EPFL Innovation Park, Lausanne, Health Valley 1015, CH · St John’s Innovation Centre, Cowley Road, Cambridge, CB4 0WS, GB · 1 Broadway, 14th Floor, Cambridge, Massachusetts 02142, US · Axis Praha, sy no. 20/4, East Wing, 4th floor, Ranka Colony Rd, Munivenkatappa Layout, Bangalore, Karnataka 560076, IN
Orphan DrugsBiologicsMedical DevicesClinical / Non ClinicalSafety & VigilanceMarket Accesspricing & reimbursementLife Cycle ManagementCMC (ChemistryManufacturing and Control)