Director Regulatory Affairs - Gurugram

We are looking for a highly skilled and experienced Regulatory Affairs Specialist to join our team in the Pharma Company. · Develop and implement regulatory strategies for medical device approvals. · Prepare and review regulatory submissions, including clinical trial applications ...

Formulations Regulatory Affairs Head is responsible for defining and executing global regulatory strategy across US EU ROW markets ensuring timely approvals regulatory compliance lifecycle management complex dosage forms. · Develop lead global regulatory strategy aligned business ...

Company Overview: · At SAR HR Consultancy, we specialize in providing strategic regulatory affairs solutions to our clients in the None industry. As a trusted partner, we aim to facilitate compliance with international regulations and optimize business systems and processes. We a ...

Fermentis Lifesciences (FLS) is a leading contract manufacturing partner for the Nutraceutical, Pharmaceutical, and health and wellness industries. · Handle end-to-end FSSAI portal operations – applications, modifications, renewals, and tracking. · Ensure compliance with FSSAI an ...

+Total Exp - 5-8 years · Supports on CER remediation including developing search strategy for literature review and state-of-the-art (SotA); evaluating the data from MAUDE, HPRA or MHRA compiling information from various sources. · Prepare/ update Clinical Evaluation Reports (CER ...

We are seeking a highly motivated and detail-oriented Regulatory Affairs Manager to join our organization. · ...

Total Exp - 5-8 years · Education - M pharma or Phd or Msc · Location - Gurgaon · Supports on CER remediation including developing search strategy for literature review and state-of-the-art (SotA); evaluating the data from MAUDE, HPRA or MHRA c ompiling information from va ...

SUMMARY OF THE JOB · • · To review and submission of product dossiers to regulatory agencies, response to queries raised by regulatory agencies. · • Provide regulatory Strategy for all new products and markets proposed by Business Development. · • Provide regulatory support fo ...

Job summary · Senior Regulatory Affairs Manager is responsible for summarizing the main purpose of the role and executing highly complex or specialized projects. Main responsibilities include directing development of product registration submission progress reports supplements am ...

This pivotal Regulatory Manager role offers you the opportunity to champion collaboration across teams, · enhancing your leadership abilities.A minimum of 6 years in regulatory affairs, · crafting strategies and guiding teams through submission processes. · Aptitude for strategic ...

Regulatory Affairs Lead will be responsible for ensuring regulatory compliance and facilitating the successful launch and maintenance of products at Takeda. · ...

Document Coordination: Collaborate with Division contacts to obtain essential documents required by Taiwan RAQA during the registration process, including license and QSD applications. · Relationship Management: Establish and maintain a positive working relationship with Taiwan R ...

+By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. · I further attest that all information I s ...

+Job summary · We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products practices and solutions to the world. · +ResponsibilitiesDevelops drives and finalizes new products approvals in India and for all products in nei ...

The Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift compliance partnering with external regulatory agencies. · We are on the leading-edge of healthcare breakthroughs that help provide reliable and ...

Takeda is guided by its purpose of creating better health for people and a brighter future for the world. · Lead the process of regulatory compliance, ensuring all products meet external and internal standards · Audit internal processes to ensure continuous compliance and identif ...

We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion. · Lead and manage regulatory projects. · ...

We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, · ensuring timely and successful product registration market authorization compliance with relevant regulatory requirement ...

The Regulatory Operations, Senior Manager ensures that the organization gains regulatory approval for new products and product amendments while maintaining the currency of product licenses and permits. · ...

Supporting the RA-FDF Team in regulatory activities to achieve department objectives. · ...