981 Clinical Affairs jobs in India
Manager-Biologics Regulatory Affairs(Clinical Trials)
Posted 2 days ago
Job Viewed
Job Description
About USV Private Limited:
USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.
Function: Biologics
Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.
Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))
Desired Qualification: M.Pharm/B.Pharm
Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.
Job Responsibilities:
1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.
2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.
3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.
4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.
5. MOH Query response
6. Product Life cycle Management
7. RA support for Plant related QMS activities
Manager-Biologics Regulatory Affairs(Clinical Trials)
Posted today
Job Viewed
Job Description
About USV Private Limited:
USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.
Function: Biologics
Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.
Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))
Desired Qualification: M.Pharm/B.Pharm
Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.
Job Responsibilities:
1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.
2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.
3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.
4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.
5. MOH Query response
6. Product Life cycle Management
7. RA support for Plant related QMS activities
Manager-Biologics Regulatory Affairs(Clinical Trials)
Posted 2 days ago
Job Viewed
Job Description
USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.
Function: Biologics
Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.
Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))
Desired Qualification: M.Pharm/B.Pharm
Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.
Job Responsibilities:
1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.
2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.
3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.
4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.
5. MOH Query response
6. Product Life cycle Management
7. RA support for Plant related QMS activities
Manager-Biologics Regulatory Affairs(Clinical Trials)
Posted 2 days ago
Job Viewed
Job Description
About USV Private Limited:
USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.
Function: Biologics
Position: Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.
Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))
Desired Qualification: M.Pharm/B.Pharm
Desired Work Experience: 5-15 years in RA-Clinical Trials for EU and US markets.
Job Responsibilities:
1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.
2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.
3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization for EU and US markets.
4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions for EU and US markets.
5. MOH Query response
6. Product Life cycle Management
7. RA support for Plant related QMS activities
Regulatory Affairs
Posted today
Job Viewed
Job Description
Company Overview
JD Lifesciences, operating under J D HEALTHCARE LIMITED, i s a fast-growing healthcare company specializing in biomedical equipment and life-saving medical solutions. We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the country.
Job Overview
We are seeking a detail-oriented and experienced professional to join our team as a Regulatory Affairs Specialist, located in Mumbai Suburban. This is a mid-level, full-time position requiring 4 to 6 years of experience. The selected candidate will play a crucial role in managing regulatory compliance and submissions in accordance with international standards and guidelines.
Qualifications and Skills
- Proven experience with regulatory submissions and a deep understanding of regulatory processes in the medical device industry.
- In-depth knowledge of FDA regulations and how they apply to product development and compliance in the healthcare sector.
- Experience with Quality Management Systems, ensuring that company processes align with regulatory and quality standards.
- Familiarity with ICH guidelines, which guide pharmaceutical product dossier creation and submission.
- Proficiency in CTD/eCTD compilation for documentation and electronic submissions of regulatory filings.
- Ability to develop comprehensive regulatory strategies that align with business goals and compliance requirements.
- Understanding of EU Medical Device Regulations (MDR) and their implications for international product submissions.
- Skilled in ensuring labeling compliance, making sure product labels meet all necessary regulatory standards.
Roles and Responsibilities
- Prepare, review and submit regulatory documents to ensure timely and efficient product approvals.
- Conduct regulatory assessments to determine applicable regulatory requirements for new products.
- Develop and implement regulatory strategies to support product development and compliance initiatives.
- Ensure product labeling meets regulatory requirements and guidelines in all relevant markets.
- Monitor changes in regulations and guidelines and communicate impacts to internal stakeholders.
- Collaborate with cross-functional teams, providing regulatory guidance and support as needed.
- Maintain regulatory files and databases to ensure all documentation is up-to-date and compliant.
- Liaise with regulatory authorities as needed to facilitate product approvals and resolve compliance issues.
Regulatory Affairs
Posted today
Job Viewed
Job Description
- preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission
- Preparation of respective CTD sections and submission of final query response to agency
- Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval
- To upload documents in national portal for respective European regulatory agency
- Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation
- Review of the mockups for all regulatory submissions and commercial supplies
- Maintenance of internal database
- Co-ordination with consultant for national submissions, product information translation, readability testing etc
- Review and approval of change control and deviations
- Coordination with customer and consultant in order to timely submissions of new applications, query responses, variations and renewals
- Review of variation packages
Skills Required
regulatory documentation, Compliance Management, Regulatory Submissions
Regulatory Affairs
Posted today
Job Viewed
Job Description
As a regulatory affairs officer, you'll need to:
- ensure that a company's products comply with the regulations of the regions where they want to distribute them
- keep up to date with national and international legislation, guidelines and customer practices
- collect, collate and evaluate scientific data from a range of sources
- develop and write clear arguments and explanations for new product licences and licence renewals
- prepare submissions of licence variations and renewals to strict deadlines
- monitor and set timelines for licence variations and renewal approvals
- work with specialist computer software and resources
- write clear, accessible product labels and patient information leaflets
- plan and develop product trials and interpret trial data
- advise scientists and manufacturers on regulatory requirements
- provide strategic advice to senior management throughout the development of a new product
- project manage teams of colleagues involved with the development of new products
- undertake and manage regulatory inspections
- review company practices and provide advice on changes to systems
- liaise with, and make presentations to, regulatory authorities
- negotiate with regulatory authorities for marketing authorisation
- take part in the development of marketing concepts and approve packaging and advertising before a product's release.
**Salary**: ₹111,861.27 - ₹643,812.53 per year
**Benefits**:
- Internet reimbursement
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
Ability to commute/relocate:
- Wagholi, Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Education**:
- Higher Secondary(12th Pass) (preferred)
**Experience**:
- total work: 1 year (preferred)
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Regulatory Affairs
Posted today
Job Viewed
Job Description
1. Review all technical documents for submission of ANDA submission and post-approval submissions.
2. Ensuring all compiled ANDAs comply with current FDA guidelines and expectations to minimize deficiencies.
3. Preparation and review of pre-ANDA meeting packages, and controlled correspondences.
4. To track all changes from time to time in the product life cycle for ANDAs. Ensure all changes comply with current FDA thinking and expectations.
5. Preparation and review of supplements for changes in ANDA. Ensured to have post-approval compliance at risk-based assessment i.e. determining and evaluating appropriate filing categories e.g. CBE-0/CBE-30/PAS.
6. To track all changes from time to time in the annual report period of approved products and ensure submission of all changes to the FDA with detailed change history.
7. Evaluation of change control/deviation and review of technical documents in its support. Facilitating regulatory audits along with another department of the plant.
8. To maintain an internal regulatory database with all requisite details and necessary supporting documentation to facilitate the operation of the regulatory affairs department within the organization.
**Skills Required**:
1. Well verse with ICH, US FDA and relevant guidelines
2. Strategic thinking and proactive planning
3. Awareness of job responsibilities
4. Decision-making and problem-solving
5. Mentoring and interpersonal communication6. Ability to inspire teammates and recognition.
**Experience Required: 8-12 Years**
**Qualification: M. Pharma/ B.Pharma**
**Job Types**: Full-time, Regular / Permanent
**Salary**: ₹1,000,000.00 - ₹1,500,000.00 per year
Schedule:
- Day shift
- Monday to Friday
**Experience**:
- total work: 8 years (preferred)
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Regulatory Affairs
Posted today
Job Viewed
Job Description
- Preparation of dossiers as per the regulatory requirements of different countries, Dossier submission for ROW market
- Maintain the proper status of Registered and submitted dossier in respective countries
- Communication with the manufacturers to obtain the documents as per the regulatoryrequirements for import registration
- To solve the queries raised during registration followed by submissions of requested documents
- Communication with the manufacturers to obtain the documents as per the regulatoryrequirements
- To solve the queries raised during registration followed by submissions of requested documents
- FSSAI licensing submissions
- Documents preparations for import clearance of products
- Completion of documents for vendor approval system
*
**Qualifications**:
M.Sc, B. Pharm, M.Pharm
**Salary**: ₹350,000.00 - ₹400,000.00 per year
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Regulatory Affairs
Posted 18 days ago
Job Viewed
Job Description
Company Overview
JD Lifesciences, operating under J D HEALTHCARE LIMITED, i s a fast-growing healthcare company specializing in biomedical equipment and life-saving medical solutions. We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the country.
Job Overview
We are seeking a detail-oriented and experienced professional to join our team as a Regulatory Affairs Specialist, located in Mumbai Suburban. This is a mid-level, full-time position requiring 4 to 6 years of experience. The selected candidate will play a crucial role in managing regulatory compliance and submissions in accordance with international standards and guidelines.
Qualifications and Skills
- Proven experience with regulatory submissions and a deep understanding of regulatory processes in the medical device industry.
- In-depth knowledge of FDA regulations and how they apply to product development and compliance in the healthcare sector.
- Experience with Quality Management Systems, ensuring that company processes align with regulatory and quality standards.
- Familiarity with ICH guidelines, which guide pharmaceutical product dossier creation and submission.
- Proficiency in CTD/eCTD compilation for documentation and electronic submissions of regulatory filings.
- Ability to develop comprehensive regulatory strategies that align with business goals and compliance requirements.
- Understanding of EU Medical Device Regulations (MDR) and their implications for international product submissions.
- Skilled in ensuring labeling compliance, making sure product labels meet all necessary regulatory standards.
Roles and Responsibilities
- Prepare, review and submit regulatory documents to ensure timely and efficient product approvals.
- Conduct regulatory assessments to determine applicable regulatory requirements for new products.
- Develop and implement regulatory strategies to support product development and compliance initiatives.
- Ensure product labeling meets regulatory requirements and guidelines in all relevant markets.
- Monitor changes in regulations and guidelines and communicate impacts to internal stakeholders.
- Collaborate with cross-functional teams, providing regulatory guidance and support as needed.
- Maintain regulatory files and databases to ensure all documentation is up-to-date and compliant.
- Liaise with regulatory authorities as needed to facilitate product approvals and resolve compliance issues.