Regulatory Affairs Executive

6 months ago

Ahmedabad Gujarat, India Aegis Lifesciences Pvt Ltd Full time

Title/Designation: Regulatory Executive

Based at: Ahmedabad

Industry: Medical Devices manufacturing (Class III)

Qualification: Postgraduate or equivalent in Pharma/Medical Devices domain

Experience: more than 2 years will be preferred

Reports to: Head of RA / RA Manager

**About us**:
Aegis Lifesciences, established in 2008, is a distinguished manufacturer and exporter of medical devices, headquartered in India. Renowned for its state-of-the-art facilities, Aegis specializes in the production of high-quality absorbable and non-absorbable haemostats, serving a diverse clientele across the globe.
- **Global Reach**: Aegis caters to quality-conscious markets worldwide, including the EU, NHS-UK, CIS, Central America, Russia, LATAM, MENA, SA, and SEA
- **Remarkable Growth**: With an impressive yearly growth rate exceeding 30%, Aegis has demonstrated substantial success in expanding its product portfolio and market presence
- **Quality Standards**: Aegis upholds the highest quality standards, holding certifications such as ISO:13485, MDSAP, and CE (Class III medical devices). The company's facilities are registered with the United States Food and Drug Administration (FDA), reinforcing its commitment to quality and compliance

Aegis Lifesciences continues to drive innovation and excellence in the medical device industry, making significant contributions to global healthcare.

**About the role**:
**Responsibilities**:
The Senior RA Executive shall report to the Head of QA/RA, and is responsible to assist him in the following areas:

- Leading new product registrations and license renewals in various regulated/semi regulated countries
- Compliance for international as well as local regulations for various class of medical devices in the regions where they are distributed.
- Preparing the responses against the queries raised during the registration of medical device products.
- To Lead QA/RA team and ensure the preparation and maintenance of regulatory/quality SOPs within the company
- Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment
- Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes
- Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects
- Keep abreast of International legislation and guidelines of current product line in India
- Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements
- Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements
- Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labeling changes
- Review of SOPs, BPRs, specifications and change control to ensure compliance
- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks
- Drives resolution of issues, communicates issues, impact and outcomes to the management team
- Responsible for ensuring compliance to the submission standards, procedures and policies in India
- Support Commercial Department in business development such as product evaluation and pre-launch activities
- Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc.
- More than 2 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry
- Bachelor’s degree in relevant field. Master's is desirable
- Ethical behaviour and high level of integrity
- Good teamwork, independent and committed to works across functional department
- Possess good negotiation and dispute resolution skills
- Demonstrated experience operating in a regulated environment
- Ability to read, analyse and interpret governmental regulations & reports, scientific or clinical publications and data
- Ability to write reports, business correspondence, and quality procedures
- Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities

**Address**:
215/216, Mahagujarat Industrial Estate,

Sarkhej-Bavla Road, At: Moraiya, Po: Changodar, Ta: Sanand

A-504, Swati Trinity, Applewoods Township,

Near Shantipura Circle, Ahmedabad, Gujarat 380054

**Job Types**: Full-time, Permanent

Pay: ₹325,000.00 - ₹500,000.00 per year

**Benefits**:

- Commuter assistance
- Health insurance
- Paid sick time
- Provident Fund

Schedule:

- Day shift
- Fixed shift

  • Regulatory Affairs Executive

    6 months ago

    Science City, Ahmedabad, Gujarat, India Vetenza India Pvt Ltd. Full time

    Hiring 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

    6 months ago

    Bodakdev, Ahmedabad, Gujarat, India Sunchem Industrial Corporation Full time

    Regulatory affairs executive - B Pharm or M Pharm with 2 years plus experience in similar profile or work area. **Job description**: - Preparing Dossiers for registration of products in various ROW markets and query response submission - Legalization of FDCA documents for respective country registration - Arrangement of Sample for registration submission...

  • Regulatory Affairs Officer

    6 months ago

    Ahmedabad, Gujarat, 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 Executive

    6 months ago

    Ahmedabad, Gujarat, India Fusion Market Research Full time

    Regulatory Affairs Executive act as a link between companies and regulatory authorities, ensuring that products are manufactured, tested and distributed in compliance with appropriate legislation. **Responsibilities**: - studying scientific and legal documents to check they meet legal requirements. - Gathering, evaluating, organising, managing and...

  • Regulatory Affairs Executive

    6 months ago

    Ahmedabad, Gujarat, India Sunrise Remedies Full time

    Sunrise Remedies Job Opening for Regulatory Affairs Executive (RA). **Experience**: 0 To 1 Year **(Fresher and Experience Can Also Apply)** **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining...

  • Regulatory Affairs Executive

    6 months ago

    Ahmedabad, India Prime Placement Full time

    Position: 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 Executive

    6 months ago

    Vadodara, Gujarat, India Ronak Group Full time

    Looking for an Enthusiastic, Efficient & Trustworthy Senior Executive - Regulatory Affairs for a Leading MNC “**Ronak Group”** **Company: Ronak Group (MNC)** Position**:Executive / Senior Executive - Regulatory Affairs** Experience: 2 to 7 Years Location: Vadodara, India We are looking for Energetic & Goal Oriented **Executive / Senior Executive -...

  • Regulatory Affairs Executive

    1 month ago

    Sachin, Surat, Gujarat, India Globela Pharma Pvt. Ltd. Full time

    **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...

  • Executive Regulatory Affairs Specialist

    4 weeks ago

    Ahmedabad, Gujarat, India Lifelancer Full time

    About UsLifelancer is a renowned platform connecting talent with opportunities in life sciences, pharma, and IT domains.Job Title: Sr. Executive Regulatory AffairsLocation: Sola AhmedabadWork Mode: On-siteEstimated Salary: ₹800,000 - ₹1,200,000 per annumWe are hiring for a highly skilled Sr. Executive Regulatory Affairs professional to join our...

  • Regulatory Affairs Executive

    6 months ago

    Ahmedabad, Gujarat, India Winston HR Services,Ahmedabad Full time

    POSITION : REGULATORY AFFAIRS QUALIFICATION : B. PHARM, M. PHARM, (B.S.C, M.S.C) EXPERIENCE : 0.6 TO 3 JOB LOCATION : AHMEDABAD MO. 7383005000 SHIVANI WINSTON HR SERVICES **Salary**: ₹20,000.00 - ₹30,000.00 per month Schedule: - Day shift **Experience**: - total work: 1 year (preferred) Work Location: In person **Speak with the...

  • Regulatory Affairs Executive

    6 months ago

    Ahmedabad, Gujarat, India SUNTARA COSMETICS Full time

    **Responsibilities** - Review formulations and claims and provide regulatory guidance to ensure full compliance to regulations including mandatory standards. - Oversight of the preparation and filing of regulatory documents with the FDA and international regulatory bodies; setting the standards for and reviewing all submissions to assure adequacy and...

  • Regulatory Affairs Executive

    3 months ago

    Sola, Ahmedabad, Gujarat, India WEST-COAST PHARMACEUTICAL WORKS LTD Full time

    We are hiring for _**Sr. Executive - Regulatory Affairs. **_ Qualification: B.pharm/M.pharm Experience - 3 to 5 years only Location - Sola, Ahmedabad Work mode - on site **Role & responsibilities: - ** - Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline. - Technical documents like Raw Material and finished products...

  • Regulatory Affairs Executive

    6 months ago

    Ahmedabad, Gujarat, India Winston HR Services,Ahmedabad Full time

    POSITION :REGULATORY AFFAIRS EXPERIENCE : 0 TO 1 QUALIFICATION : B.PHARM, M.PHARM. JOB LOCATION : AHMEDABAD mo: 7383005000 SHIVANI WINSTON HR SERVICES **Salary**: ₹15,000.00 - ₹20,000.00 per month Schedule: - Day shift **Experience**: - total work: 1 year (preferred) Ability to Commute: - Ahmedabad, Gujarat (required) Ability to...

  • Regulatory Affairs Officer

    3 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. -...

  • Officer - Regulatory Affairs

    6 months ago

    Bodakdev, Ahmedabad, Gujarat, India Sunchem Industrial Corporation Full time

    Regulatory affairs executive - B Pharm or M Pharm with 2 years plus experience. **Job description**: - Preparing Dossiers for registration of products in various ROW markets and query response submission - Legalization of FDCA documents for respective country registration - Arrangement of Sample for registration submission from respective team - Prior...

  • Regulatory Affairs Assistant

    6 months ago

    Jarod, Vadodara, Gujarat, India Briyosis Soft Caps Pvt Ltd Full time

    Job description **Company Description** Briyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels...

  • Regulatory Affairs Executive

    3 months ago

    Sanand, Ahmedabad, Gujarat, India Samarthhrconsultant Full time

    Regulatory Affairs Min: 01 year 3 yrs\ sanand Ahemdabad Pay: From ₹12,000.00 per month **Experience**: - total work: 1 year (preferred) Work Location: In person Application Deadline: 26/10/2024 Expected Start Date: 23/10/2024

  • Regulatory Affairs Executive

    3 months ago

    Sarkhej, Ahmedabad, Gujarat, India Delwis Healthcare Pvt Ltd Full time

    **Job description** - Good communication skills client handling, Preparing/ checking and submitting technical files and compilation of dossiers in CTD/ACTD format as required for semi regulated countries/markets, - Product life-cycle management in ROW markets, - Handling product registration, - Providing regulatory support for out-licensing projects. -...

  • Regulatory Affairs Executive

    2 months ago

    Vatva, Ahmedabad, Gujarat, India Samarthhrconsultant Full time

    Regulatory Affairs Min: 01 year 3 yrs Pacific Countries Vatva Ahemdavad Pay: From ₹12,000.00 per month **Experience**: - total work: 1 year (preferred) Work Location: In person Application Deadline: 08/11/2024 Expected Start Date: 06/10/2024

  • Regulatory Affairs Executive

    2 months ago

    Sarkhej, Ahmedabad, Gujarat, India Delwis Healthcare Pvt Ltd Full time

    **Job description** - Good communication skills client handling, Preparing/ checking and submitting technical files and compilation of dossiers in CTD/ACTD format as required for semi regulated countries/markets, - Product life-cycle management in ROW markets, - Handling product registration, - Providing regulatory support for out-licensing projects. -...