Regulatory Specialist

The position As a RA Specialist, the ideal candidate will be responsible to design RA Strategy from late stage development and throughout Life cycle of the device project, prepare and submit high quality files to the authorities achieving fast approvals. Act as an ambassador for assigned medical devices/device part of combination products. This...

Department: Regulatory Affairs Rare Endocrine Disorders Job Level: 7 Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory...

Job TitleSecurity specialist - Regulatory & StandardsJob DescriptionJob title:Security specialist - Regulatory & StandardsYour role:As the Product Security process expert you will responsible for maintaining and enhancing the global Philips Product Security policy and process framework, driving the future strategic directions on product security...

Description : Primary contact with investigative sites during study maintenance and -when assigned-, sitestart-up activities, with responsibility for collection of the required investigator andregulatory essential documents to ensure EC/IRB/Third body/Regulatory Authoritysubmissions are made within the timelines agreed with project management and...

Description : Primary contact with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and...

Key Responsibilities : Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for...

Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...

Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...

Department – Clinical Reporting Unit Are you an experienced Medical Writing specialist with a strong background in regulatory medical writing? Do you have a passion for clear and concise communication of clinical data? We are looking for a Medical writing Specialist to join our Clinical Reporting team at Novo Nordisk. If you are ready for a new...

Job Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business...

Key Responsibilities : Drive the submission and delivery process with the Global Publishing team to ensure timely dispatch and archival of submissions as per the agreed timelines. Delivery of submission packages to agreed schedule and technical specification Advise and assist authors with the preparation of submission content and use of GSK...

About PositionWe are looking for GRC Specialist with 8+ Years of experience.Role: GRC SpecialistLocation : Noida/ Bangalore/ Hyderabad/ PuneExperience : 8 - 12 YearsJob Type : FTEWhat You'll DoLead the GRC and provide strategic direction and oversight for all GRC activities within the organization.Develop and implement GRC frameworks, policies, and...

The position As a Medical Writing Specialist, you will be responsible for performing medical writing tasks of high complexity and acting as a project manager. Your role will involve planning, developing, and overseeing regulatory documents across all phases of clinical development. This includes but is not limited to, the preparation of Protocols,...

Payroll Governance Specialist Payroll Governance Specialist Req ID: Department: DEEx Payroll Division: Talent & Culture Location: Bengaluru About the role At ANZ, we’re shaping a world where people and communities thrive, driven by a common goal: to improve the financial wellbeing and sustainability of our millions of customers.  The...

About Position We are looking for GRC Specialist with 8+ Years of experience. Role: GRC Specialist Location : Noida/ Bangalore/ Hyderabad/ Pune Experience : 8 - 12 Years Job Type : FTE What You'll Do Lead the GRC and provide strategic direction and oversight for all GRC activities within the organization. Develop and implement GRC frameworks,...

Description The Regulatory Affairs Manager 1 with Business Development role sits in the Regulatory Business Development group and is of key importance in the delivery of AstraZeneca business development portfolio to ensure license transition in the most efficient and customer focused manner. The role comprises of two main accountabilities,...

Description The Regulatory Affairs Manager 1 with Business Development role sits in the Regulatory Business Development group and is of key importance in the delivery of AstraZeneca business development portfolio to ensure license transition in the most efficient and customer focused manner. The role comprises of two main accountabilities, described...

About the job TMF Specialist is to perform all duties related to the timely processing of essential and non-essential clinical trial documents to facilitate study startup, drug shipment, eTMF maintenance and support eTMF inspection readiness activities Location : Bangalore/Chennai Experience Skills Ability to interact with Clinical and Regulatory team...

Prime Video is changing the way people watch movies and TV shows, with millions of titles available on-demand on Kindle, Fire TV, mobile devices, game consoles, Internet-connected TVs, and Blu-ray players. Content Compliance and Quality is an essential component of Prime Video Trust & Safety charter. We are seeking an innovative and analytical Program...

Digital Document Specialist – DDS – 4xx Grade Short Description: If you are passionate about our mission, we want you to make a difference here by providing subject matter expertise to our clients with transaction management. You will be responsible for ensuring that all aspects of transaction management for clients are completed on time and...