Sr. Regulatory Affairs

The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical research organization. This position will play a crucial role in ensuring compliance with regulatory requirements and providing strategic regulatory guidance to internal teams and clients. The Sr. Manager,...

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: ...

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

We are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...

Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. Typical duties include: studying scientific and legal documents to check they meet legal requirements Pay: ₹20,000.00 per...

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team. Job Titles: Executive / Senior Executive / Assistant Manager Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) WFOResponsibilities:1. Dossier collation and...

We are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...

Greetings from Right Staff One of our client who are into Medical Devices Are looking for a Regulatory Affairs person at Delhi NCR Job Description - **Experience minimum 5 Years and above compulsory** Designation - Regulatory Affairs/QA Affairs Time - Day Shift Location - Delhi NCR **Responsibilities**: - 1. Identify regulatory and post market...

**1.** **Drug Regulatory Affairs - Job description** Ø Prepare CTD, ACTD Dossiers and file regulatory submissions Ø Perform assessments of new or revised products Ø Manage complaint documentation (including investigation and Ø closure) Ø Respond to inquiries from regulatory bodies Ø Should be technically well versed with requirements for...

Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levelsCoordinate 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 officialsCoordinate with Global...

As a Medical Affairs professional, you will contribute actively to devise and implement the medical affairs strategy, be a specialist in the therapy areas and allotted products/portfolios. Role: Medical Affairs Manager Experience: 6 10 Years Location: Mumbai (Work from Office) Responsibilities: Handle all Medico Marketing activities & Medical Services,...

As a Medical Affairs professional, you will contribute actively to devise and implement the medical affairs strategy, be a specialist in the therapy areas and allotted products/portfolios.Role: Medical Affairs ManagerExperience: 6 10 YearsLocation: Mumbai (Work from Office)Responsibilities:Handle all Medico Marketing activities & Medical Services, Medical...

Position Overview:As the Government Affairs and Public Policy Lead, one will play a pivotal role in shaping our organization's interactions with government entities like NITI Aayog, Municipalities, Smart city officials, Police departments, Ministry of Road Transport and Highways of India by managing the relations and getting closures for smart parking...

Senior / Labelling SpecialistJob Description:We are seeking a highly skilled and experienced Senior Labelling Specialist to join our team and take on a pivotal role in the development and approval of labelling documents for our vaccine portfolio. As a Senior Labeling Specialist, you will be responsible for overseeing all aspects of labeling, from initial...

Oppo India is hiring for Manager Public Affairs. Experience 10-12 Years Education Graduate/Post Graduate Full Time Location Gurgaon Work From Office 1)Analyze and interpret policies and regulations pertaining to IT & Electronics industry. 2)Engage with Policy makers, Industry Associations such as ICEA, CII, MAIT, PHD Chamber of commerce etc. to monitor...

Looking at professional experience of min 5 years into Global Regulatory Affairs and who has actively done submissions for global markets such USFDA, ANVISA, etc as the companies plan to expand to Europe and US markets. Incumbent should be carrying strong knowledge of relevant regulations and guidelines for medical devices, including FDA 21 CFR, EU Medical...

Lead Corporate Affairs Role - Lead - Corporate AffairsFunction / Department - Corporate Affairs Location - DelhiJob Description:- Experience in stakeholder engagement, public affairs, corporate affairs, policy influencing/advocacy, program management and sustainability. This should include significant experience in working with others to drive business goals...

Job description Roles and Responsibilities - To manage new registration / re-registration / query responses/variation filings for abroad markets. - Ensuring that quality standards are met and submissions of Dossiers meet strict deadlines. - Review labelling and labels for compliance with regulatory requirements. - Review technical documents like BMR,...

Purpose of the role:This role will be responsible for Medical affairs activities for assigned existing Products / therapy and disease areas, collaborate with Commercial teams, training etc to drive medico-marketing activities, actively contribute to Medial activities with external experts,/ KOLs, implement Product/TA specific approved medical initiatives,...

Qualifications : B.Pharm/ M. Pharm/ M.Sc.Location: For two years in Brazil Office followed by Office in MumbaiJob descriptionResponsibilitiesEnsure change management, post approval changes to ANVISAReview of technical documents for new submissions, post approval changes (Individual Protocol, HMP).Writing PATE for post approval changesRespond to technical...