The Opportunity:

The Associate Director, Regulatory Operations, Europe will play a key role in supporting the growing European Regulatory Affairs organization by leading the operational planning and execution of regulatory submissions across the region. This role partners closely with the European Regulatory Affairs team to operationalize regional regulatory strategies and ensure successful execution of regulatory submissions to health authorities across the EU, EEA, UK and Switzerland.

Working cross-functionally with regulatory strategy, clinical, CMC, nonclinical, and quality teams, the Associate Director will drive submission planning, manage regulatory documentation, and coordinate cross-functional teams to deliver high-quality submissions in accordance with global and regional regulatory operations processes and systems. While primarily focused on the European region, this role operates within Global Regulatory Operations and may support regulatory submissions in other regions as business needs evolve.

Primary Responsibilities:

• Serve as the primary Regulatory Operations partner supporting the European Regulatory Affairs team to execute regional regulatory strategies.

• Lead operational planning, preparation, publishing, and submission of regulatory dossiers to European health authorities including EMA, EU/EEA national authorities, MHRA, and Swissmedic.

• Lead regulatory submission planning and operational execution for major regulatory applications including Marketing Authorisation Applications (MAA), ensuring effective coordination of submission timelines, dossier assembly, publishing, and submission readiness.

• Develop and manage detailed regulatory submission timelines, proactively driving cross-functional teams to ensure timely preparation, review, and delivery of submission components.

• Coordinate cross-functional activities required for regulatory submissions, including document preparation, review cycles, and final submission readiness.

• Publish and perform quality control of regulatory submissions in eCTD format using DocuBridge, ensuring compliance with applicable regulatory technical requirements.

• Manage regulatory submission content and metadata within Veeva Vault RIM, ensuring accuracy and completeness of regulatory information and documentation.

• Support preparation and coordination of key regulatory deliverables including Clinical Trial Applications (CTA), scientific advice packages, pediatric plans, and lifecycle management submissions.

• Provide operational guidance to cross-functional teams regarding submission requirements, document standards, and regulatory timelines.

• Partner with Global Regulatory Operations to ensure alignment of regional submission processes, systems, and regulatory documentation standards.

• Manage external publishing vendors and consultants supporting regulatory submission activities.

• Provide regulatory operations support for global submissions as needed, collaborating with Global Regulatory Operations colleagues across regions.

• Manage regulatory procedures via EMA IRIS platform, including scientific advice, orphan designation, and other applicable EMA interactions.

• Ensure accuracy, completeness, and consistency of structured regulatory data and metadata across Veeva Vault RIM and European health authority systems (e.g., CTIS, IRIS, eSubmission Gateway).

• Coordinate submission activities across multiple European submission channels and platforms, ensuring alignment of dossier content and data across eCTD and portal-based submissions.

• Lead operational support for EU regulatory lifecycle activities, including variations, renewals, and other post-approval submissions, ensuring compliance with EU procedural requirements.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or related discipline.

• 8+ years of experience in regulatory operations, regulatory affairs, or regulatory submission management within the biotechnology or pharmaceutical industry.

• Demonstrated experience preparing and publishing eCTD submissions to global health authorities.

• Strong understanding of European regulatory submission requirements and procedures.

• Hands-on experience using Veeva Vault RIM for regulatory information management.

• Hands-on experience using DocuBridge for regulatory publishing.

• Demonstrated ability to lead regulatory submission timelines and coordinate cross-functional submission deliverables.

• Strong understanding of regulatory document management, publishing standards, and regulatory submission lifecycle processes.

• Proven ability to manage multiple complex regulatory submissions simultaneously while maintaining high quality and compliance.

• Strong organizational, communication, and stakeholder management skills.

• Familiarity with EMA IRIS platform and associated regulatory procedures (e.g., scientific advice, orphan designation).

• Experience managing regulatory data, metadata, and submission tracking across multiple health authority systems and platforms.

Preferred Skills:

• Experience supporting regulatory submissions to European health authorities including EMA, MHRA, Swissmedic, or EU national competent authorities.

• Experience supporting Marketing Authorisation Applications (MAA) or other major marketing applications.

• Experience working in global regulatory teams supporting both regional and global regulatory submissions.

• Oncology or rare disease regulatory experience is considered an advantage.

• Experience managing regulatory publishing vendors or external regulatory consultants.

• Experience working within a growing or evolving regulatory organization.

• Experience navigating EU regulatory procedures (centralised, decentralised, or mutual recognition).

• Familiarity with evolving EU regulatory data standards (e.g., SPOR/IDMP) is a plus.

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#LI-Hybrid #LI-LO1

Divea's main goal is to expand Humanity's technology tree by developing value-added products for society based on graphene membranes. In particular our goal is the research, development and large-scale production of nanopores in a monatomic layer of graphene for gas separation, particularly for capturing CO₂ from industrial emissions.

We don't care where you studied or which diploma you have, we are looking for problem-solvers who get things done with a high sense of urgency. If you want to build products that are added value to society, this is the place for you. We are looking for proof of exceptional abilities and high motivation. 

As a Roll-to-Roll Lead Engineer, you role is to design, build and test a prototype production line for producing graphene membranes in a continuous fashion. This is part of our efforts in scaling up our production and moving away from batch processes. You have to expect very rapid prototyping iterations. Most of these steps are being developed from scratch by our team and require a critical thinking and a first-principle approach.

For the more traditional description:

What you will be doing

• Use mechanical engineering fundamentals, analysis, and design software to create complete mechanical design concepts for robust, low-risk, and cost-efficient machine designs that will complete the project scope within the budget and schedule parameters defined by the project scope documents
• Support the fabrication and assembly processes for the project as required
• Participate in mechanical debug activities to ensure the machine assembly and debug phases of the project are completed on schedule
• Work with component suppliers to specify and acquire quotes for commercial machine components
• Designing systems for gas injections.
• Designing systems for heating and cooling.
• Simulating Gas flow through a reactor.
• Designing systems for the winding, unwinding and keeping under tension graphene rolls.

Basic Qualifications

• Background in Mechanical Engineering or a relevant engineering discipline
• Experience with the design, building and testing of roll-to-roll production lines.

Additional Requirements

• Must be willing to work extended hours and/or weekends, necessary to support critical milestones

Your level and base salary will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills, education, and experience.

Base salary is just one part of your total rewards package at Divea. You may also be eligible for long-term incentives, in the form of company stock, stock options, or long-term cash awards, as well as potential discretionary bonuses and the ability to purchase additional stock at a discount through an Employee Stock Purchase Plan.