Regulatory Affairs

A reputable and well-established pharmaceutical company is actively recruiting a **Regulatory Affairs Manager **to be based in **Riyadh, KSA**. This role will be working under RA Department and will be supporting local regulatory activities in Saudi Market. **The main responsibilities will include but not limited to**: - Review all regulatory submission...

Regulatory Affairs Supervisor| Riyadh, Saudi Arabia **The Company**: An aggressive expansion program together with acquisitions in new vertical markets have created an exciting opportunity to join a dynamic multinational team dedicated to furthering growth plans for the group. **About the Role**: The Regulatory Affairs Supervisor is responsible to...

Job TitleRegulatory Affairs Manager, Hospital Patient Monitoring METAJob DescriptionJob title:Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.You are responsible for Create regulatory awareness level as determined within the organization. Supports implementation of simplified yet robust...

Job TitleRegulatory Affairs Manager, Hospital Patient Monitoring METAJob DescriptionJob title:Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.You are responsible forCreate regulatory awareness level as determined within the organization.Supports implementation of simplified yet robust...

**Job Description**: Your role: As an integral part of the team, your role would entail overseeing day-to-day operational activities, and collaborating with both internal and external stakeholders to ensure timely submission and approvals of regulatory activities while proactively communicating the progress of such activities. Your deep understanding of the...

Compile and submit, in a timely manner, regulatory documents according to regulatory requirements and regular follow up on the submitted files.Ensure timely submissions as well tightly manage deficiency responses.Work with market regulatory manager to develop a detailed understanding of regulatory guidelines and technical requirements in assigned...

• In alignment with the Hiring Manager, is responsible for developing and implementing regulatory strategic plans for product registration and lifecycle management.• Lead the preparation of regulatory submissions including New Drug Submissions (NDSs).• Provide regulatory inputs and guidance to responses to EMA queries in relation to clinical...

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the...

• In alignment with the HiringManager, is responsible for developing and implementing regulatorystrategic plans for product registration and lifecyclemanagement.• Lead the preparation ofregulatory submissions including New Drug Submissions(NDSs).• Provide regulatory inputs andguidance to responses to EMA queries in relation to clinicalefficacy and...

Recommends changes for labelling , manufacturing, marketing and clinical protocol for regulatory compliance.Monitors and improves tracking/control systems.Keeps abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Recommends strategies for earliest possible approvals of clinical trials applications.

Recommends changes for labelling ,manufacturing, marketing and clinical protocol for regulatorycompliance.Monitors and improvestracking/control systems.Keeps abreast ofregulatory procedures and changes.May directinteraction with regulatory agencies on definedmatters.Recommends strategies for earliestpossible approvals of clinical trialsapplications.

Identifies information sources andresources for local regulations.Collects andcoordinates information on regulatory requirements for in vitrodiagnostic devices, quality, preclinical and clinical data to meetapplicable regulations.Assist in deviceregistration activities - agency communication; registrationrequirements; participation in submission...

Identifies information sources and resources for local regulations.Collects and coordinates information on regulatory requirements for in vitro diagnostic devices, quality, preclinical and clinical data to meet applicable regulations.Assist in device registration activities - agency communication; registration requirements; participation in submission...

Responsible for productsregistration, renewals, and ensuring approvals via GHAD systems andother SFDA systems, including reimbursement follow up ifany.Responsible for the post-marketsurveillance of medical devices for all related reports inaccordance with the regulatory agencyguidelines.Facilitates all related technicalinformation and applicable...

Responsible for products registration, renewals, and ensuring approvals via GHAD systems and other SFDA systems, including reimbursement follow up if any.Responsible for the post-market surveillance of medical devices for all related reports in accordance with the regulatory agency guidelines.Facilitates all related technical information and applicable...

Work Mode: Onsite **Responsibilities**: - [Company Introduction]_ Tencent is a world-leading internet and technology company that develops innovative products and services to improve the quality of life of people around the world. Founded in 1998 with its headquarters in Shenzhen China, our guiding principle is to use technology for good. We are not only...

ideal candidate for EU regulatory affairs should haveProven EU regulatory affairs experienceExcellent leadership and communication skills,Negotiation & liaising experience with EU FDA.Works with Biocon Biologics head of RA to derive the global development strategy partnering with GRL (Global Regulatory Lead).

Provide strategic leadership anddirection for all medical affairs activities, including clinicaldevelopment, regulatory affairs, and pharmacovigilance for a Phase2 ALS programEstablish and nurturecollaborative partnerships with key stakeholders, including,regulatory agencies, and clinical researchorganizations.

Provide strategic leadership and direction for all medical affairs activities, including clinical development, regulatory affairs, and pharmacovigilance for a Phase 2 ALS programEstablish and nurture collaborative partnerships with key stakeholders, including, regulatory agencies, and clinical research organizations.

**Wondering **what’s** within Beckman Coulter Diagnostics? Take a closer look.**: **At first glance, you’ll** see that for more than 80 years **we’ve** been dedicated to advancing and **optimizing** the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. **W**e’re** building a...