Regulatory Affairs Assistant
Puno radno vreme Ugovor

Regulatory Affairs Assistant abbreviated "RAA"

About OCSiAl Group:

OCSiAl is the world’s largest producer of graphene nanotubes. Our team consists of more than 500 employees located in Europe, USA and Asia. OCSiAl’s mission is to improve the specific properties of all base materials, making the world a better place for all living beings. We are pursuing this mission by developing universal nanotube solutions and introducing them into the manufacturing industry. This is leading to the creation of a new generation of nano augmented materials and end products, whose previously unobtainable properties will become the standard for consumer expectations.

Job and Role Description: 

The Regulatory Affairs Assistant is an entry-level, developing role within the PSRA Department. The role exists to build the department's internal capacity and resilience: the Assistant learns SDS management end-to-end, alongside a second Assistant, so that the two can back each other up permanently and remove the single point of failure that exists today when SDS production depends on one person's availability.

The primary and first-priority learning objective is SDS management: understanding how Safety Data Sheets and labels are produced, checked, released, archived, and kept compliant across OCSiAl's markets. As competence grows (indicatively over the first 12–24 months, subject to performance evaluation), the RA-Assistant progressively takes on cross-checking of releases and a rotating share of the department's broader regulatory-compliance tasks, escalating only genuinely critical (high-hazard) cases to the Lead Manager.

Responsibility (Tasks) – core, from day one:

• Learn and apply SDS production for hazardous mixtures/substances, with the support of the department's SDS software (ExESS).
• Learn how to create new-from-scratch SDSs as well as duplicate/translated SDSs for existing formulations.
• Screen safety documents (e.g., supplier SDSs) for chemical components involved.
• Support review and adjustment of existing SDSs as formulations, classifications, or regulations change.
• Assist with production and departmental review of label templates (GHS/CLP), under supervision.
• Archive all data related to each SDS request and release, including present master documents, following the department's document-retention rules.
• Provide frequent, specific status reporting on SDS/label workload to the Lead Manager.

Responsibilities (Tasks) – introduced progressively, once SDS fundamentals are mastered:

• Cross-check the other Assistant's SDS/label releases before publication (mutual back-up model), and have releases cross-checked in return.
• Take on a rotating share of non-SDS regulatory-compliance support tasks alongside the second Assistant.
• Support PCN dossier creation and updates (new dossiers and amendments to existing ones).
• Support GHS/CLP labelling management, including keeping label templates current per product and per country.
• Support regulatory-change monitoring: periodic follow-up on worldwide regulatory updates via ExESS, reporting relevant changes to the Lead Manager.
• Support UFI number management.
• Provide logistics support for external laboratory analyses (scheduling, sample tracking, documentation).
• Support existing notification follow-up (e.g., US-EPA, EU-REACH, KR-REACH, UK-REACH, KKDIK) as capacity allows, under guidance.
• Support EU compliance requirements for non-EU production sites, once trained.
• Escalate genuinely critical or high-hazard (O/T/F) cases to the Lead Manager via the department's Think Tank process, rather than deciding independently.

Required Qualifications:

• Proficient in English (written and spoken) is a must.
• Strong attention to detail and a structured, methodical way of working, critical for compliancesensitive documentation.
• Good communication and analytical skills; comfortable asking questions and working closely with a supervising RAA/Lead Manager while learning.
• Able to follow procedures precisely and to respect deadlines, including while still building expertise.
• MS Office proficient; willingness and aptitude to learn dedicated regulatory/SDS software (e.g., ExESS) and, in time, portals such as ECHA REACH-IT.
• Minimum of a bachelor’s degree (or equivalent), ideally in a scientific, chemical, EHS, or regulatory-related field.
• Genuine interest in regulatory affairs, product safety, or EHS as a career path.

 Required Experience: 

• No prior SDS or regulatory-affairs experience is required, this is a developing role and full training is provided. 
• Any prior exposure to the chemical industry, EHS, laboratory work, or regulatory/compliance environments is an asset but not mandatory. 

Permissions (only after 2Y and a positive evaluation): 

During the initial training period, all SDS releases, label releases, and regulatory submissions require review and sign-off by the Lead Manager or an authorized, more senior RAA. No independent release authority is granted from day one. 

What we offer:

• An attractive position in a global and dynamic company;
• This is full time remote positon;
• Opportunity for professional and personal development;
• Competitive employment conditions.
• Predictable & Consistent Work Schedule.
• Work on exciting projects that push the boundaries of what’s possible.

Side notes:

• CV in English is required;
• Only shortlisted candidates will be contacted.

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