Regulatory Affairs Specialist
3 weeks ago
Job Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: - Regulatory Compliance: Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations. - Submission Management: Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies. - Regulatory Strategy: Develop and implement regulatory strategies to support product development and commercialization. - Regulatory Intelligence: Stay up-to-date with changing regulatory requirements and provide guidance to internal stakeholders. - Audits and Inspections: Coordinate and manage regulatory audits and inspections. - Labeling and Advertising: Review and approve product labeling and advertising materials for regulatory compliance. - Regulatory Agency Interactions: Communicate with regulatory agencies, such as the FDA, to address questions and concerns. - Regulatory Documentation: Maintain and manage regulatory documents, such as regulatory submissions, approvals, and correspondence. - Training and Guidance: Provide regulatory training and guidance to internal stakeholders. - Compliance Monitoring: Monitor company activities for compliance with regulatory requirements. Skills : - Must have good knowledge of Regulatory Submissions - Must have good understanding of Regulatory Research - Must be familiar with chemical industry-specific regulations and guidelines.
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Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Tek Support Full time ₹ 1,04,000 - ₹ 1,30,878 per yearJob Title:Regulatory Affairs Specialist Med/Pharma (Female)Location:RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...
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Regulatory Affairs Executive
2 weeks ago
Mumbai, India Morpheus Human Consulting Full timeReference Code: - 319-58 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Job Title: Regulatory Affairs Executive - Vile Parle - Mumbai - **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like...
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Regulatory Affairs Operations Specialist
3 days ago
Pune, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: - International Registrations - Upload, Verify, and Validate the data with new Regulatory Information to the RIM database - Maintain Registration &Licensing Information - Create Submission Packages for International Registrations - Initiate Renewals with...
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Regulatory Affairs Executive
2 weeks ago
Mumbai, India Morpheus Human Consulting Full timeReference Code: - 319-54 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Our client is one of the leading Manufacturing company of Animal Healthcare Products since 1977. They have around 20 dedicated sales offices in India. - They market wide range of poultry and cattle products....
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Hyderabad, India Dyaz Innovate Full timeJob Description Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a...
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Regulatory Affairs Specialist
4 weeks ago
Ahmedabad, Gujarat, India, Gujarat Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...
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Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Chemical Manufacturing Full time ₹ 6,00,000 - ₹ 18,00,000 per yearJob Title:Senior Executive / Assistant Manager – Regulatory AffairsLocation:Mumbai, India (On-site)Employment Type:Full-time | PermanentExperience Required:3 to 8 yearsIndustry:Chemicals | Pharmaceuticals | Food & BeveragesJob Function:Legal | Quality Assurance | Regulatory AffairsSalary: up to 9 LPAAbout the Role:We are hiring for aSenior Executive /...
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Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 12,00,000 per yearPosition:Sr. Executive / Asst. Manager / Deputy Manager – Regulatory Affairs (Domestic)Location:Andheri, MumbaiQualification:M. Pharm. (Experienced preferred)Job Description – Regulatory Affairs (Domestic)The role requires strong expertise in theDrugs & Cosmetics Act and Rules,FSSAI regulations, andFDA-related activities. The profile will ensuretimely...
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Delhi, India Danaher Life Sciences Full timeJob Description - 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. We're building a culture that...
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Regulatory Affairs
1 week ago
Mumbai, Pithampur, India Gepach International Full time US$ 80,000 - US$ 1,20,000 per yearResponsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.1. Dossier Preparation and ReviewOversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with...
