Executive – Enterprise Risk and Regulatory Affairs

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier...

Company Description SurgeWay Biosciences Pvt Ltd is an established exporter of Pharmaceutical Drugs and Niche Healthcare Products. With a strong track record of domestic and international operations spanning 40 years, SurgeWay is led by a dynamic young team that brings a professional approach and long-term business growth outlook. Our expertise in...

Position : Executive Department : Regulatory Affairs Location : Kandivali - West, Mumbai Qualification - M Sc/ B Pharm/ M Pharm Experience : 4 - 8 years and above Role Responsible for activities related to own submission and support for contract manufacturing projects of Europe market Job Profile : To liaise with customers on matters related to their...

Regulatory Affairs Specialist - CMC Variations/Submissions 12 month contract - Immediate start Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes. Key Responsibilities: CMC Change Control...

Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:CMC Change Control Assessment:...

Job Description Looking for a candidate having experience in Regulatory affairs domain for one of the medical equipments manufacturng industry. Roles and Responsibities: Regulatory Compliance: Liaison as required between the corporate international regulatory team, SA & ME Region SSU’s and regulators to support SSU and corporate compliance...

Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levels Coordinate for acquiring / renewal of FDA/FSSAI licenses, product approvals, chemist intimations/ approvals, maintain regulatory documentation and follow up on any Corrective action directed by the FDA officials Coordinate with Global...

Job Description Summary Regulatory Affairs Associate is responsible for the timely preparation and submission of adequate and accurate ANDAs and supplements in eCTD format through effective interactions with various stakeholders pertaining to documents that are a part of submission. Also can responsible for oral solids (tablets, capsules) or sterile...

Job Description Regulatory Affairs Manager (European Union expertise)Medical Device Company. Tucson, AZOnsite (relo over time) 140k Talentry is looking for a Regulatory Affairs expert with medical device experience in the European Union (EM MDR).  This expert will aid in the preparation of documentation, submissions, applications, responses, adverse...

Are you passionate about creating an awesome campus experience? At KCLAS , the Executive/Sr. Executive in the Office of Student Affairs is key to making student life vibrant and supportive. You'll be planning cool events, helping out with student issues, running orientation, and using data to make things even better. If you're organized, love advocating for...

Specific activities and responsibilities: Review the drug product dossier section ( specifically 3.2.P.2 and 3.2.P.3 ) as per the EU regulatory requirement. Aware of regulatory requirements, and technical knowledge of various pharmaceutical dosage forms. Project coordination and management skills CMC regulatory requirements for other than...

Key Deliverables Dossier compilation of initial MAA for Europe Market Response to EU authorities deficiency Scientific Advice Variations and Supplements (Type IA, IA, Type IB Type Timely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review. Hands...

JOB DESCRIPTION Executive - Corporate Affairs ·        To assist Assistant Manager – Corporate Affairs in matters related to VIP Travel o  Build relationship with various VIP passengers and their protocols o  Understand the travel requirements of VIP passengers and facilitate them accordingly o  Interaction with AOCS / Cargo staff...

An opportunity to work with a Multi-Billion Global FMCG An opportunity to drive policy advocacy for a large scale FMCG Setup About Our Client Our client is a Multi-Billion Global FMCG with its presence in more than 50+ countries across the globe with dedicated Manufacturing and R&D Centres to India Job Description Plant...

Role: Program Lead – Enterprise Risk Management Location : Bangalore Key Responsibilities: Support the execution and roll out of ERM framework to various business units in alignment with Infosys strategic vision and objectives. External risk profiling - Gathering of external data/ insights through secondary research to monitor emerging developments...

Job Description Summary The Director, Enterprise Quality Auditing is responsible for providing oversight and direction to the Enterprise Quality Auditing (EQA) function. Responsibilities include but are not limited to:- Overseeing and directing the India based auditing team who are responsible for the global external Quality auditing program of in-line...

Job Description Position Overview: The Director, State Affairs (Western Region) plays a critical role in coordinating state affairs initiatives and managing state lobbying activities in assigned region(s) on behalf of the organization. This involves coordinating efforts among association members, national, state, and local trade associations, as well as...

Roles and Responsibility About The Role The incumbent will report to IndiaGovernment Affairs Head and be based in Delhi (require some travel within India).  Responsibilities Support in the execution of publicpolicy campaign across the full range of policy areas thatimpact organisation’s business in the field of onlinegaming and...

Description Collate and review CMC documents (i.e. Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports etc.) from F&D, ADL, QA, production, packaging department and review of data for ANDA preparation, deficiency response, annual reports and supplements. Prepare and review the ANDA’s sections. Compile controlled...

Job Description The work we do at BioTechnique has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join BioTechnique and help create the next...