Job Description

The Position

The Regulatory Affairs Specialist supports the Regional Regulatory agenda by providing support on any regulatory affairs matters required for commercial operations, with a focus on supporting the ongoing Kuwait Regulatory activities. The below job description is not intended to be exhaustive, additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.

Your Responsibilities Governance of the Kuwait regulatory landscape and requirements for local registration: preparing, submitting and negotiating with regional regulatory bodies to obtain approval or clearance of premarket registration as well as post market compliance Provides expertise in translating regulatory requirements into practice, workable plans Collaborate with the regional regulatory team and local regulatory lead to ensure compliance to local market regulations and technical file submissions Collaborate with Product Managers and Marketing teams: Assures timely regulatory clearances and registrations for new product launches, renewals to ensure timely market access, continuous product availability and compliance Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements Compiles all materials required in submissions, license renewal and annual registrations Identifies the regulatory impact : changes of labelling, manufacturing, marketing for regulatory compliance, submitting the required change notifications Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes Directing interactions with regulatory agencies on defined matters, working with advocacy principles to ensure rapid and optimal registration for new products and indications, as well as line extensions and ensuring the effective and compliant regulatory maintenance of existing products Delivering regulatory focus within the region with the team of regional regulatory responsible. Ensuring communication, disseminating relevant information to key stakeholders Building capacity across the organisation for regulatory topics using community forums, emails and face to face meetings Educates internal and external customers regarding submissions issues regarding products. Acts as subject matter expert to management and project teams on critical regulatory issues May serve as a contact with affiliates to achieve regulatory compliance through regional regulatory network To collaborate with the Product Quality and Safety lead regarding the requirements for Adverse event reporting and recall management ensuring compliance to regional regulations To actively support local organizations and marketing, sales and logistic departments to obtain documents related with regulatory affairs such as certificates, declarations, etc., needed ad required for tender processes, contracts and /or any commercial activity To support audit activities, ensuring compliance to the divisional requirements Check/approve promotional materials as routed through internal tools for compliance to promotional practice regulations and the external necessary approvals

Compliance You are expected to adhere through your conduct to all applicable laws and regulations as well as to the high integrity standards as set forth by Roche.

Who You Are Kuwaiti national will be preferred for this role You hold a BSc/MSc degree in Pharmacy, Medical, Biomedical, Biochemistry, Biotechnology or related. Being a Qualified Pharmacist is preferred You have at least 2 to 3 years work experience in Regulatory Affairs within the healthcare industry. Having experience in Regulatory Affairs in Medical device is preferred You have proven knowledge with Regulations of FDA, CE, ISO 9001 / 13485 You built experience dealing with business leaders, business units and regulatory authorities You have a tactical mindset and are able to connect the dots You have advanced interpersonal skills and are able to understand individual needs and motivation You are able to work both independently and in a team environment (team player) You have advanced collaboration and negotiation skills, and are able to communicate clearly and professionally You are a self-starter, creativity, have advanced organizational skills, and are able to manage projects independently from start to finish You are fluent in English and Arabic, both verbally and in writing. Mastering an additional language is considered a plus

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.