Regulatory Documentation Executive

4 weeks ago

Haridwar, India PYRAX DENTAL Full time

**Key Responsibilities**:
**Regulatory Documentation Management**:

- Prepare, review, and maintain all regulatory documentation required for product registrations, including dossiers, technical files, and submission packages.
- Ensure the documentation meets the regulatory requirements of local and international regulatory bodies (e.g., FDA, EMA, CDSCO, etc.).
- Coordinate with internal departments (e.g., R&D, Quality Assurance, Manufacturing) to gather accurate product data and technical information.
- Ensure proper formatting, compilation, and submission of regulatory documents within required timelines.

**Regulatory Submissions and Approvals**:

- Submit regulatory filings for product approvals, licenses, and renewals to relevant regulatory authorities.
- Track and follow up on submissions and approvals, ensuring all documents are processed within the specified timelines.
- Collaborate with regulatory agencies to resolve queries and provide any additional information required during the approval process.

**Compliance Monitoring**:

- Monitor changes in regulatory requirements and ensure all internal documentation processes and product registrations are updated accordingly.
- Review and update product labels, packaging, and advertising materials to ensure compliance with current regulations.
- Support internal teams with regulatory audits and inspections, ensuring all documentation is available and compliant.

**Record-Keeping and Documentation Control**:

- Maintain an organized and easily accessible filing system for all regulatory documentation.
- Ensure all documentation is stored in compliance with company policies and industry best practices, ensuring confidentiality and data integrity.
- Regularly update and maintain regulatory submission trackers, status reports, and compliance checklists.

**Cross-functional Collaboration**:

- Work closely with the product development, quality assurance, and legal teams to ensure all regulatory requirements are considered throughout the product lifecycle.
- Provide regulatory guidance and support for new product development and market expansion.
- Assist with the preparation of responses to regulatory queries and post-market surveillance documentation.

**Regulatory Research and Reporting**:

- Stay updated on industry regulations, guidelines, and standards relevant to the company’s products.
- Assist in preparing and maintaining internal regulatory compliance reports.
- Provide recommendations on regulatory strategies for new markets or product modifications based on evolving regulations.

Pay: ₹18,000.00 - ₹24,000.00 per month

**Benefits**:

- Cell phone reimbursement

Schedule:

- Day shift

Supplemental Pay:

- Overtime pay
- Quarterly bonus

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (required)
- Regulatory reporting: 1 year (required)

Work Location: In person

Application Deadline: 23/11/2024
Expected Start Date: 23/11/2024

  • Quality Assurance Executive

    4 weeks ago

    Haridwar, India PYRAX DENTAL Full time

    **Key Responsibilities**: **Quality Assurance Monitoring and Auditing**: - Conduct regular audits of manufacturing processes, materials, and finished products to ensure compliance with quality standards and regulatory requirements (e.g., GMP, ISO). - Perform internal audits of systems, processes, and documentation to ensure they align with company policies...

  • Quality Control Executive

    4 weeks ago

    Haridwar, India PYRAX DENTAL Full time

    **Key Responsibilities**: **Quality Control Testing & Inspections**: - Perform in-process, pre-release, and final inspections of raw materials, intermediate products, and finished goods to ensure they meet established quality standards and specifications. - Conduct tests on raw materials, packaging materials, and finished products using appropriate...

  • Pharmaceutical - QA Officer

    6 hours ago

    Haridwar, India Y4U ULTIMATE INDUSTRIAL SKILL TRAINING SOLUTIONS PVT. LTD. Full time

    QA Floor Knowledge - Documentation, Audit, GMP & WHO - SOP knowledge - Drug Regulatory Affairs **Salary**: ₹20,000.00 - ₹35,000.00 per month Schedule: - Morning shift Ability to commute/relocate: - Haridwar, Uttarakhand: Reliably commute or planning to relocate before starting work (required) **Education**: - Bachelor's...

  • Sales Coordinator

    3 weeks ago

    Haridwar, India Industrial Automtion & Logic Solution Full time

    A Sales Coordinator in an Automation company plays a crucial role in supporting the sales and marketing team by managing various administrative tasks and facilitating the sales process. Here's a detailed profile of a Sales Coordinator in an Automation company: **Job Title**: Sales Coordinator **Key Responsibilities**: - **Lead Management**: - Assign leads...

  • Financial Management Executive

    2 days ago

    Haridwar, Uttarakhand, India Anshu Rani (Proprietor Of Anshu Enterprises) Full time

    Job SummaryAnshu Rani (Proprietor Of Anshu Enterprises) seeks a highly skilled and experienced Accounts Executive to manage the day-to-day accounting operations. The successful candidate will be responsible for monitoring accounts payable, making and checking TDS/GST, and filing documents on time.Key Responsibilities- Monitor and account for all accounts...

  • Civil Engineer

    2 weeks ago

    Haridwar, India LOXIM INDUSTRIES LIMITED Full time

    Job Title: Civil EngineerExperience: 5-7 YearsIndustry: Greenfield ProjectLocation: Devprayag, Tehri, UttarakhandCompany: Loxim Industries Ltd.Reports To: Managing DirectorCompany Overview:Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have...

  • Civil Engineer

    2 weeks ago

    Haridwar, India LOXIM INDUSTRIES LIMITED Full time

    Job Title: Civil EngineerExperience: 5-7 YearsIndustry: Greenfield ProjectLocation: Devprayag, Tehri, UttarakhandCompany: Loxim Industries Ltd.Reports To: Managing DirectorCompany Overview:Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have...

  • Customer Care

    4 weeks ago

    Haridwar, India Kalpaamrit Full time

    Job Title: Customer Care & Billing Executive (Female) Company: Kalpaamrit Location: [Haridwar India] **Salary**: ₹10,000 - ₹15,000 per month Work Hours: 9:00 AM - 6:00 PM **Job Description**: Key Responsibilities: Handle customer inquiries and provide excellent customer service Manage billing and related documentation Maintain accurate records and...

  • Supply Chain Executive

    4 weeks ago

    Haridwar, India Talent'd HR Solutions Full time

    **Job ID**: - IN10684505695 **Supply Chain Executive (Import/Export Operations, Procurement)**: - Haridwar, Uttarakhand, India - Electronic Components / Semiconductors - 3-5 Years - Bachelor Degree - Indian - English - As per the Market Standard - **Job Roles and Responsibilities**: Doing all day-to-day activities of SCM team which includes: Preparing...

  • Civil Engineer

    2 weeks ago

    Haridwar, India LOXIM INDUSTRIES LIMITED Full time

    Job Title: Civil EngineerExperience: 5-7 YearsIndustry: Greenfield ProjectLocation: Devprayag, Tehri, UttarakhandCompany: Loxim Industries Ltd.Reports To: Managing DirectorCompany Overview:Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have...

  • Civil Engineer

    2 weeks ago

    Haridwar, India LOXIM INDUSTRIES LIMITED Full time

    Job Title: Civil EngineerExperience: 5-7 YearsIndustry: Greenfield ProjectLocation: Devprayag, Tehri, UttarakhandCompany: Loxim Industries Ltd.Reports To: Managing DirectorCompany Overview:Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have...

  • Executive Billing

    2 weeks ago

    Haridwar, India Zaneka Pharmaceuticals Pvt Ltd Full time

    **Key Responsibilities** - **Billing Operations**: - Generate accurate invoices for dispatched pharmaceutical products. - Verify dispatch documents such as delivery challans, packing lists, and shipping instructions before billing. - Ensure billing aligns with purchase orders, sales orders, and terms of agreements. - **Documentation and Compliance**: -...

  • Quality Specialist

    5 days ago

    Haridwar, India USANA Health Sciences Full time

    Who We Are Looking For We are looking for a skilled and detail-oriented professional to join the USANA’s India manufacturing team as a Quality Specialist based in Haridwar and/or Pontasahib . In this position, you will align with the directives of the Home Office Quality Department to develop quality assurance systems and carry out routine quality...

  • Inventory Executive

    4 weeks ago

    Haridwar, India Amorvet Full time

    Document daily deliveries and shipments to update inventory. Prepare detailed reports on inventory operations, stock levels, and adjustments. Evaluate new inventory to ensure it’s ready for shipment. Perform daily analysis to predict potential inventory problems. Pay: From ₹28,000.00 per month Schedule: - Day shift **Experience**: - total work: 1...

  • Civil Engineer

    2 weeks ago

    Haridwar, India LOXIM INDUSTRIES LIMITED Full time

    Job Title: Civil EngineerExperience:5-7 YearsIndustry:Greenfield ProjectLocation:Devprayag, Tehri, UttarakhandCompany:Loxim Industries Ltd.Reports To:Managing DirectorCompany Overview:Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have...

  • Civil Engineer

    2 weeks ago

    Haridwar, India LOXIM INDUSTRIES LIMITED Full time

    Job Title: Civil EngineerExperience:5-7 YearsIndustry:Greenfield ProjectLocation:Devprayag, Tehri, UttarakhandCompany:Loxim Industries Ltd.Reports To:Managing DirectorCompany Overview:Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have...

  • Civil Engineer

    2 weeks ago

    Haridwar, India LOXIM INDUSTRIES LIMITED Full time

    Job Title: Civil EngineerExperience:5-7 YearsIndustry:Greenfield ProjectLocation:Devprayag, Tehri, UttarakhandCompany:Loxim Industries Ltd.Reports To:Managing DirectorCompany Overview:Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have...

  • Civil Engineer

    2 weeks ago

    Haridwar, India LOXIM INDUSTRIES LIMITED Full time

    Job Title: Civil EngineerExperience:5-7 YearsIndustry:Greenfield ProjectLocation:Devprayag, Tehri, UttarakhandCompany:Loxim Industries Ltd.Reports To:Managing DirectorCompany Overview:Since our inception in 1977, LOXIM has been combining the power of chemistry with strategic business acumen to create innovative products for a global market. We have...

  • E-com Accounts Executive

    4 weeks ago

    Haridwar, India PYRAX POLYMARS Full time

    **E-commerce Operations**: - Generate invoices for e-commerce orders and coordinate dispatch processes. - Manage e-commerce stock levels to ensure product availability and timely restocking. - Book couriers and track shipments to ensure timely deliveries. **Financial Documentation & Reporting**: - Prepare and maintain the monthly commission sheet for...

  • Field Sales Executive

    4 weeks ago

    Haridwar, India Focal Skill Development Private Limited Full time

    1. Sales Target achievement 2. Lead generation 3. Product knowledge 4. Relationship building 5. Collaboration 6. Sales documentation and reporting 7. Continues learning 8. Market research 9. Upselling & cross selling Pay: ₹10,000.00 - ₹15,000.00 per month Schedule: - Day shift - Morning shift **Education**: - Higher Secondary(12th Pass)...