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Jobs at Voisin Consulting Life Sciences (VCLS) (Now Hiring) — 2 open

Voisin Consulting Life Sciences (VCLS) logoVoisin Consulting Life Sciences (VCLS)

Document Specialist

Bengaluru, Karnataka, India · Hybrid

Mid level

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

Voisin Consulting Life Sciences (VCLS) logoVoisin Consulting Life Sciences (VCLS)

Director, Business Development

Lausanne, Vaud, Switzerland · Hybrid

Senior+

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 …

Skills: Business Development, Client Acquisition, Strategic Planning, Partnership Building, Revenue Growth

Voisin Consulting Life Sciences (VCLS) logo

Document Specialist

Voisin Consulting Life Sciences (VCLS)

Bengaluru, Karnataka, India • Hybrid

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Mid level

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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

Related keywords

eCTDNeeSeDokFDAEMAMHRASwissmedicHealth CanadaCTDRegulatory AffairsCMCClinicalDossier CompilationMicrosoft WordMicrosoft ExcelMicrosoft PowerPoint

About Voisin Consulting Life Sciences (VCLS)

LinkedInVisit site

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)
View all jobs at Voisin Consulting Life Sciences (VCLS)

About Voisin Consulting Life Sciences (VCLS)

LinkedInVisit site

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)
View all jobs at Voisin Consulting Life Sciences (VCLS)

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