Global Regulatory Submission Publisher

Vor 3 Tagen


Basel, Schweiz Warman O'Brien Vollzeit

A Global Regulatory Submissions Publisher is required for a long-term contract with a global pharma based in Basel.

**Major Accountabilities**:

- Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool) and dispatch activities related to regulatory submissions (i.e., INDs, BLAs/NDAs, MAAs, HA A to Qs, Global Labeling, Annual Reports, etc.).
- Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements US, EU, LACan, MOW).
- Partners with Operations Submission Managers and a publishing team located in 3 regions (US, EU and India) and actively functions in a global capacity.
- Liaises /collaborates with cross functional team members and document authors (Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high-quality submissions.
- Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
- Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
- Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.
- 5-8 years submission publishing experience in Pharma or related industry
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Effective interpersonal skills, strong written and oral communication and presentation skills.
- Project management and time management skills to manage multiple ongoing projects simultaneously.
- Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- EU/EFTA Citizen or valid Swiss work Permit

**Role Details**:

- Long-term contract - 18 months+
- Global Pharma
- Competitive rates of pay
- Hybrid working considered

**Job Types**: Full-time, Freelance

**Salary**: CHF69.00 - CHF71.00 per hour

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Basel, BS: Reliably commute or planning to relocate before starting work (required)

Work Location: One location



  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The...


  • Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Basel, Schweiz Global Personal Partner Vollzeit

    **EINFÜHRUNG**: Our profession and our passion are "HR Management". Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of services in the field of Human Resources at 21 locations in German-speaking Switzerland. For our client, an international technology company in Basel, we are looking...


  • Basel, Schweiz Sandoz Vollzeit

    1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. - Global Drug...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...


  • Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Basel, Schweiz Novartis Vollzeit

    394918BR **Global Program Regulatory Manager (GPRM - Cardiometabolic)**: Switzerland **About the role** 26 major approvals, 13 major submissions and 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing...


  • Basel, Schweiz Ironwood Pharmaceuticals Vollzeit

    VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...


  • Basel, Schweiz Ironwood Pharmaceuticals Vollzeit

    VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, and maintenance of regulatory databases and archives. **Here’s What You’ll Do**: Oversees the regulatory submission of CTAs to national HAs world-wide as required:...


  • Basel, Schweiz Coopers Group AG Vollzeit

    Global Regulatory Affairs Director We are looking for a person who will develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans. **Responsibilities** - Participate in or lead...


  • Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1863 - About us Who we are Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...


  • Basel, Schweiz Novartis Vollzeit

    1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Moderna Therapeutics is seeking a Director of Regulatory Labeling to support new and existing programs to be based in Basel or other International Moderna hub. This is a newly created role intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for...


  • Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1863 About Us Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. We...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: **Here's What You’ll Do**: Provide leadership for regulatory CMC aspects of product development projects Lead and drive all CMC submission activities (planning, Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines Develop effective CMC regulatory strategies for submissions (e.g....


  • Basel, Schweiz Novartis Vollzeit

    26 major approvals, 13 major submissions and 2,000 associates worldwide. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease...


  • Basel, Schweiz Stratpharma Vollzeit

    An ambitious forward thinking Dermatology company based in the centre of Basel have created an exciting hybrid QARA Associate opportunity that will work closely with the International QARA Director in managing the company’s global QA and RA functions. This is a highly successful company who have an impressive 200% year on year growth and are going through...