Executive Regulatory Affairs

**Job Description: Regulatory Affairs Executive (Fresher to 3 Years Experience)** **Position**: Regulatory Affairs Executive **Department**: Regulatory Affairs **#### **Key Responsibilities**: - **Regulatory Submissions**: - Prepare and submit regulatory documents to health authorities (FDA, EMA, TGA, etc.) for new products, amendments, and...

We are seeking a skilled Regulatory Affairs Executive to join our team at BioMatrix Healthcare. This full-time position is based in Ahmedabad and requires expertise in regulatory standards and processes.Key Responsibilities:Manage regulatory submissions, ensure compliance, and facilitate product registrations to support market expansionReview regulatory...

About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...

Company OverviewBioMatrix Healthcare Private Limited 100 export-oriented company headquartered at Ahmedabad Gujarat India was established in 2007 with a thought of Supporting Life Worldwide The company is engaged in R D and manufacturing of oral solids liquids and dry syrups Our manufacturing facility has been accredited by WHO-GMP successfully...

**Qualifications**: Any Graduate of B.Pharm / M.Pharm / MBA (pharmaceuticals/IB) / M.sc / Any Relevant Degree in Pharmaceuticals. **Roles & Responsibility**: - To ensure that a company's products comply with the regulations of the regions where they want to distribute them - To develop explanations for new product licenses and license renewals to strict...

About Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...

About Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

About Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

Company OverviewBioMatrix Healthcare Private Limited is a 100 export-oriented company headquartered at Gujarat, India. Established in 2007, the company supports life worldwide by engaging in R&D and manufacturing of oral solids, liquids, and dry syrups. Our WHO-GMP accredited facility has successfully completed an EU-GMP audit and complies with ANVISA,...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Professional to join our team at SDP HR Solution. As a key member of our regulatory team, you will be responsible for preparing and submitting DMF applications to various regulatory agencies around the world.Main ResponsibilitiesPrepare DMF applications for Brazil, US, and ROW markets in...

Job DescriptionSponsor regulatory affairs for DMF submission, ensuring compliance with Brazil, US, and ROW market regulations.Key Responsibilities:Prepare New Drug Master Files (DMFs) and amendments according to agency requirements.Coordinate with cross-functional teams to obtain necessary documents for filing.Review vendor documents for key starting...

To prepare/submit/review technical documentation for the international registration of products - To prepare/update/review the Technical Master File for the current product - To prepare/review Technical Change Notifications to the Regulatory Authority - To review Application/ Query related to DCGI (GMP, Manufacturing license), state FDA, local FDA, Central...

Company OverviewParadise Placement Consultancy is a renowned consultancy firm providing expert services in regulatory affairs and quality assurance.Job DescriptionAs a Regulatory Affairs Specialist - Quality Assurance Expert, you will be responsible for preparing and reviewing documentation required for ISO 9001:2015, EN ISO 13485: 2016, Quality Management...

Studying scientific and legal documents to check they meet legal requirements - Gathering, evaluating, organising, managing and collating information in a variety of formats - Submitting information and responding to queries from bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) - Maintaining familiarity with company product...

We are hiring for our rapidly growing client in the biotech IVD manufacturing business, based in Bengaluru.Job Title: Regulatory Affairs AssociateLocation: BengaluruEducation:Bachelor’s or Master’s degree in Engineering, Biomedical Sciences, or a related discipline.Certifications in regulatory compliance or quality systems (e.g., RAC, CQE) are a...

BioMatrix Healthcare is a dynamic company that requires a passionate and experienced Regulatory Affairs Executive to join our team. This mid-level position is based in Ahmedabad and involves managing regulatory submissions, ensuring compliance, and facilitating product registrations.Qualifications and Skills:In-depth knowledge of FDA Guidelines for...

DMF API Submission experience is must Preparation of New Drug Master Files as well as DMF amendments for Brazil US and ROW market according to respective agencies requirements Preparation of Applicant part of DMF for Brazil US and ROW market Preparation of all administrative statements for respective authority requirements Drafting of regulatory...

Mandatory Skills RequiredBring in and ensure unification, synergy, consolidation, quality, and consistency across various processes, policies, culture, internal systems and external market forces in the state of Gujarat with Ideal Companies.Role PurposeBring in and ensure unification, synergy, consolidation, quality, and consistency across various processes,...

Export Documentation Prepare and verify export documents such as commercial invoices packing lists and certificates of origin Shipping and Logistics Coordinate with freight forwarders shipping lines and customs brokers to ensure timely and efficient shipment of pharmaceutical products Regulatory Compliance Ensure compliance with export...