Regulatory Affairs
4 weeks ago
- Developing and implementing regulatory strategies for product approval and market compliance
- Ensuring all regulatory submissions and documentation are accurate and in compliance with relevant regulations
- Collaborating with crossfunctional teams to provide regulatory guidance and support
- Reviewing and approving product labeling advertising and promotional materials for compliance
- Conducting regulatory research to stay updated on changes in regulations and guidelines
- Preparing and submitting regulatory filings including 510(k)s PMAs and other regulatory submissions
- Participating in regulatory agency interactions and audits
- Assessing and communicating potential impact of regulatory changes on the business
- Managing regulatory documentation and records
- Participating in the development and review of SOPs work instructions and quality system regulations
- Bachelors degree in a scientific or technical field such as biology chemistry or pharmacy
- 3 years of experience in a regulatory affairs role in the healthcare or pharmaceutical industry
- Knowledge of FDA regulations and other regulatory requirements
- Experience with regulatory submissions and approvals such as 510(k)s PMAs or IDEs
- Strong understanding of quality management systems and regulatory compliance
- Excellent analytical and problemsolving skills
- Effective written and verbal communication skills
- Detailoriented with strong organizational abilities
- Ability to collaborate and work effectively in crossfunctional teams
- Experience interfacing with regulatory agencies and notified bodies
cross-functional collaboration,regulatory strategy,analytical skills,documentation,organizational abilities,regulations,fda regulations,communication skills,regulatory submissions,quality management systems,compliance,regulatory affairs
-
Regulatory Affairs Executive
5 months ago
Ahmedabad, India Prime Placement Full timePosition: Regulatory Affairs Assistant - Cosmetic Industry Department: Regulatory Affairs Experience Required: 0-2 years Location: Santej, Ahmedabad Salary Range: 2.2 LPA - 3 LPA Roles & Responsibilities: 1. Handling Legal Documents and Regulatory Affairs: - Assist in the preparation, review, and submission of regulatory documents. - Maintain and...
-
Regulatory Affairs Specialist
1 month ago
Ahmedabad, Gujarat, India Vyana Consultancy Full timeRegulatory Affairs Role OverviewThe Regulatory Affairs role at Vyana Consultancy is critical to ensuring compliance with all regulations and guidelines governing our industry. This position plays a key part in guaranteeing that our company's products meet the necessary regulatory standards, enabling us to bring safe and effective products to market.Key...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Vyana Consultancy Full timeRegulatory Affairs Role at Vyana ConsultancyVyana Consultancy is seeking a highly skilled Regulatory Affairs professional to join our team. In this role, you will play a critical part in ensuring our organization's products meet the necessary regulatory standards, enabling us to bring safe and effective products to market.Key Responsibilities:Develop...
-
Regulatory Affairs Professional
4 weeks ago
Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeJob Title: Executive - Regulatory AffairsJob Description:We are seeking a highly skilled and experienced Regulatory Affairs Professional to join our team at Ikamate HR India Pvt. As an Executive - Regulatory Affairs, you will be responsible for preparing and reviewing dossiers in ACTD, CTD or country-specific formats for the ROW market. You will also be...
-
Regulatory Affairs Specialist
4 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Preparation of dossiers as per the ACTD CTD (Module I II III IV and V)...
-
Regulatory Affairs Specialist
4 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key ResponsibilitiesDossier preparation as per the ACTD CTD (Module I II III IV and V) guideline.Technical...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ikamate HR India Pvt. The successful candidate will be responsible for preparing and reviewing dossiers in various formats, coordinating with QA/QC departments, and ensuring compliance with regulatory...
-
Regulatory Affairs Officer
6 months ago
Ahmedabad, India Swastik Placement Agency Full time**Position : Regulatory Affairs Officer/Executive (Female)** **Education : B Pharm (Preferably)** **Experience : 1-2 Years** **Work Profile**: 1. Preparation & Checking of Dossiers of formulation products for product registration in other countries. 2. Co-ordination with Manufacturer & our partner in country (With their regulatory person) 3. Travel may...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the JobSkills: Regulatory, Compliance, Regulatory Affairs, Regulatory Documentation, Regulatory Submissions, Regulatory Reporting, ICH-GCPJob Overview:This is a Full-Time position in Ahmedabad, requiring 4-6 years of experience.Key Qualifications and Skills:Regulatory affairs experience within the pharmaceutical sectorKnowledge of regulatory frameworks...
-
Regulatory Affairs Officer
2 months ago
Odhav, Ahmedabad, Gujarat, India Nest Healthcare Pvt Ltd Full time**Position**: Regulatory Affairs Specialist **Location**: Odhav. Ahmedabad **Department**: Regulatory Affairs **Reports to**: Regulatory Affairs Manager / Director Job Summary: Key Responsibilities: - **Compliance Monitoring**: Monitor changes in regulations and guidelines to ensure ongoing compliance with local and international regulations. -...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India SWASTIK PLACEMENT AGENCY Full timeRegulatory Affairs ResponsibilitiesAt SWASTIK PLACEMENT AGENCY, we are seeking a skilled Regulatory Affairs Officer to facilitate compliance with regulations and ensure seamless product registration. Key responsibilities include:• Reviewing and analyzing regulations related to ANDA, patent and exclusivity, prior approval supplements, and changes to...
-
Regulatory Affairs Specialist
4 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key ResponsibilitiesPreparation of dossiers as per the ACTD CTD (Module I II III IV and V) guideline.Technical document...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Preparation of dossiers as per ACTD CTD (Module I II III IV and V) guidelines.Technical document...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeJob Title: Executive - Regulatory AffairsJob Description:We are seeking a skilled Regulatory Affairs Specialist to join our team at Ikamate HR India Pvt. The ideal candidate will have experience in preparing and reviewing dossiers, as well as coordinating with QA/QC departments and regulatory authorities.Key Responsibilities:Preparation and review of...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeRegulatory Affairs RoleAs a Regulatory Affairs Specialist at Ikamate HR India Pvt, you will be responsible for preparing and reviewing dossiers in compliance with ACTD, CTD, or country-specific formats for global markets. This includes coordinating with QA/QC departments for technical and legal documents, preparing artwork for registration, and managing...
-
Regulatory Affairs Officer
5 months ago
Science City, Ahmedabad, Gujarat, India Vetenza India Pvt Ltd. Full timeHiring for a **REGULATORY AFFAIRS OFFICER ** for our **Ahmedabad **location. Freshers with good knowledge should apply **Key Responsibilities**: - Assist in the preparation, compilation, and submission of regulatory documents, such as drug master files (DMFs), technical dossiers, and regulatory filings, to health authorities and regulatory agencies. -...
-
Regulatory Affairs Executive
6 months ago
Science City, Ahmedabad, Gujarat, India Vetenza India Pvt Ltd. Full timeHiring for a **REGULATORY AFFAIRS EXECUTIVE** for our **Ahmedabad **location. **Key Responsibilities**: - Assist in the preparation, compilation, and submission of regulatory documents, such as drug master files (DMFs), technical dossiers, and regulatory filings, to health authorities and regulatory agencies. - Maintain and update regulatory documentation...
-
Regulatory Affairs Executive
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob SummaryWe are seeking an experienced Regulatory Affairs Executive to join our team at Lifelancer, a leading platform connecting talent with opportunities in Life Sciences, Pharma, and IT.ResponsibilitiesPrepare dossier submissions as per the ACTD CTD (Module I II III IV and V) guidelines.Develop and review technical documents, including raw material and...
-
Regulatory Affairs Lead
22 hours ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to provide direct Worldwide Regulatory support to various projects and products. As a key member of our team, you will be responsible for supporting strategic planning and product development efforts, and providing Regulatory support for existing products with respect to product...
-
Regulatory Affairs Director
2 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout UsLifelancer is a fast-growing consulting firm in GXP services, regulatory affairs, and pharmacovigilance space.Job OverviewWe are looking for a highly experienced Regulatory Affairs professional to join our Business Development Team.ResponsibilitiesAct as a regulatory lead for all projectsExecute and deliver all RA projects on timeDraft and compile...