Senior Regulatory Affairs Specialist

4 weeks ago

Riyadh, Saudi Arabia Cepheid Full time

**In this role, the associate**:

- Identify information sources and resources for local regulations.
- Serve as RA lead on global Market Expansion registrations for simple to medium complicated projects for initial product approvals and renewals, for assays, instruments or software, in global regions outside US and EU to ensure OTD product launches.
- Be responsible for OTD of RA deliverables to meet registration plan.
- Be responsible for providing data for relevant metrics and KPI bowlers.
- Collect and coordinate information on regulatory requirements for in vitro diagnostic devices, quality, preclinical and clinical data to meet applicable regulations.
- Use best practices and knowledge of internal or external business issues to improve products or service.
- Ensure proper filing and organization of all documents and correspondence in support of and concerning all regulatory submissions.
- Interact through written and verbal correspondence and negotiate with regulatory agencies during the strategy development and pre-submission process, as appropriate for the region.
- Negotiates and consults as needed with regulatory agencies prior to in-country studies or submissions.
- Author and prepare regulatory submission, renewal, and change submission and ensure filings are in compliance with international regulations and guidelines.
- Use knowledge of regulations and develops regulatory strategy for introducing new products to global regions to meet business priorities.
- Identify RA project deliverables and contributes to development of registration schedule.
- Prepare formal written reports, PowerPoint presentations to communicate regulatory strategies and status.
- Interact with regulatory authority/ health agencies to address queries during review.
- Actively manage and monitor submissions under review. Respond promptly and negotiate with regulatory authorities, as needed.
- Provide regulatory guidance with regard to preparation, review and approval of product labeling and promotional materials to comply with country specific requirements, as needed.
- Interact cross-functionally to generate protocols and reports that require in-country testing data for registration purposes.
- Authors and prepares regulatory registration plan based on business priority.
- Have a good relationship with regional regulatory leaders and peers to expedite approval of pending registrations.
- Maintain a "focused urgency" throughout the submission process.
- Solve complex problems; by taking a new perspective using existing solutions.
- Provide training and coordinate with department personnel from regulatory, quality, and manufacturing sites, Sales, and Marketing.
- Work independently, receiving mínimal guidance and act as a resource for colleagues with less experience.
- Provide regional regulatory requirements to NPD core team via RA Lead, as needed.
- Identify product classification based on region and intended use.
- Attend and present escalations to Regulatory Steering Committee (RSC) to enable rapid approvals and renewals of products across all global regions.
- Serve as primary contact with the regulatory agency for the registration submission under review.
- Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements is assigned regions.
- Be responsible for regulatory project timelines and management of multiple, concurrent regulatory submissions.
- Track, manage and report to leadership on regulatory review timelines.

**The essential requirements of the job include**:

- Excellent organizational skills with attention to detail and accuracy.
- Ability to work independently in a fast-paced environment with flexibility to manage changing priorities.
- Able to demonstrate a broad experience of manufacturing processes and equipment.
- Able to confidently deal with ambiguous issues and take action towards suitable solutions.
- Demonstrated excellence in communicating and presenting complex information to technical and non-technical partners.
- Proven ability to manage and prioritize multiple projects. Highly motivated, takes initiative, follow through, and complete projects in a professional and timely manner.
- IVD product experience is highly preferred.
- Prior knowledge of different databases like SAP, Sales Force, Tarius, Trackwise etc. including Agile documentation system is a bonus.
- Understands complex Regulatory Affairs concepts and should be experienced with regulations/guidelines governing development of diagnostic products.
- Excellent oral and written communication and presentation skills. Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.
- Have conceptual and practical expertise in own discipline and basic knowledge of related disciplines.
- Have knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.

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