Regulatory Affairs

3 weeks ago


Vadodara Gujarat, India Actide international Full time

**Qualification**: B.Pharma - Pharmacy or M.Pharma - Pharmacy

**Experience**: 2.0 Year **To** 4.0 Year **( Must have experience in Pharma Formulations)**

1. Preparing dossiers as per country specific guidelines

2. Countries knowledge
- Africa, South East Asia

They must have excellent organizational, analytical, project management, and communication skills.

They work frequently with other employees and team members to coordinate complex activities, often with competing priorities.

Most regulatory affairs positions are full time.

Regulatory Responsibility means a duty or responsibility, assigned to an individual by management.

Regulatory compliance is when a business follows state, federal, and international laws and regulations relevant to its operations, Regulatory compliance involves following external legal mandates set forth by state, federal, or international government.

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.

liaise with, and make presentations to, regulatory authorities.

negotiate with regulatory authorities for marketing authorization.

**Requirements**:
Minimum 2 years in regulatory affairs and should be well versed with Dossier making process as per individual country requirement (ROW market )

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

**Salary**: ₹150,000.00 - ₹300,000.00 per year

**Benefits**:

- Health insurance
- Provident Fund

Supplemental pay types:

- Yearly bonus

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

**Speak with the employer**

+91 9328903541



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

    **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 annually. Our...


  • Vadodara, Gujarat, India Vega Biotec Pvt. Ltd Full time

    Vega Biotec Pvt Ltd forms part of Vega group companies involved in manufacturing and exporting of finished pharmaceutical products and having global presence in 20+ countries. We have an opening for the following post. 1. Regulatory Affairs Executive - Qualification - B.pharma/M.pharm Experience - 2-4 year's minimum in regulatory affairs Job profile: 1....


  • 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 -...


  • Vadodara, India Vega Biotec Pvt. Ltd Full time

    Vega Biotec Pvt Ltd forms part of Vega group companies involved in manufacturing and exporting of finished pharmaceutical products and having global presence in 20+ countries. We have an opening for the following post. 1. Regulatory Affairs Executive - Qualification - B.pharma/M.pharm Experience - 5-7 year's minimum in regulatory affairs Job profile: 1....


  • Vasna Road, Vadodara, Gujarat, India Vega Biotec Pvt. Ltd Full time

    **Vega Biotec Pvt Ltd** a part of Vega group of companies having global presence and state of the art manufacturing pharmaceutical factory is having an opening for the following post. Qualification - B.Pharm/ M. Pharm Experience - 3+ years of experience in regulatory affairs for ROW market (Rest of the world) **Job Summary**: The Regulatory Affairs...


  • 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. -...


  • Vadodara, Gujarat, India Lifelancer Full time

    Job Title: Regulatory Affairs OfficerLocation: Vadodara, Gujarat, IndiaJob Type: Full-timeJob Level: ExecutiveCompany Overview: Renown Pharmaceuticals Pvt. Ltd. is a renowned contract manufacturer of soft gelatin capsules in India.The company maintains high-quality standards and aims to be a leading producer in the industry.Renown Pharma adheres to...


  • Vasna Road, Vadodara, Gujarat, India Vega Biotec Pvt. Ltd Full time

    **Vega Biotec Pvt Ltd** a part of Vega group of companies having global presence and state of the art manufacturing pharmaceutical factory is having an opening for the following post. Qualification - B.Pharm/ M. Pharm Experience - 3+ years of experience in regulatory affairs for ROW market (Rest of the world) **Job Summary**: The Regulatory Affairs...


  • Vadodara, India Alembic Pharmaceuticals Full time

    **Department **Regulatory Affairs **Location **Vadodara **Qualification **M.Pharm **Experience **3 -5 years **Job Title **Executive Prepare regulatory dossiers for different dosage forms for submission to Health authorities Must have hands on experience in Latam Countries Communicates with internal and external stakeholders to collect documents and...


  • 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...


  • vadodara, India Lifelancer Full time

    Job Title: Regulatory Affairs Officer Job Location: Vadodara, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Executive Skills:Knowledge of regulatory requirements, Excellent communication skills, Ability to interpret complex regulations, Experience with regulatory submissions, Regulatory compliance knowledge, ROW...


  • vadodara, India Lifelancer Full time

    Job Title: Regulatory Affairs Officer Job Location: Vadodara, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Executive Skills:Knowledge of regulatory requirements, Excellent communication skills, Ability to interpret complex regulations, Experience with regulatory submissions, Regulatory compliance knowledge, ROW...


  • Vadodara, Gujarat, India Integrated Resources, Inc Full time

    Job SummaryWe are seeking a highly motivated Regulatory Affairs Executive to join our team at Integrated Resources, Inc. As a key member of our organization, you will be responsible for ensuring that all company operations comply with relevant laws and regulations.Key Responsibilities:Reviewing and updating policies regularly to ensure alignment with current...


  • 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...


  • Changodar, Ahmedabad, Gujarat, India Sarian Healthcare Full time

    **Job Title**: Regulatory Officer - Exports **Department**: Regulatory Affairs **Location**: Changodar, Ahmedabad **Reports To**: Director **Key Skills and Qualifications**: - **Educational Background**: Bachelor's degree in Pharmacy, Life Sciences, Medicine, or a related field. A Master's degree in Regulatory Affairs or a related discipline is a plus. -...


  • 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...


  • vadodara, India Vega Biotec Pvt Ltd Full time

    Vega Biotec Pvt Ltd forms part of Vega group companies having state of the art manufacturing company in Vadodara and having presence in over 20 countries. Our export arm has an opening for the following post. 1. Senior Regulatory affairs executive- Qualification- Bsc/Msc Chem,B.pharma/M.pharma Experience- Minimum 4 years in RA Job Profile- 1. CTD or ACTD...


  • Science City, Ahmedabad, Gujarat, India Gp Crop are Pvt. Ltd. Full time

    To have a clear understanding of regulatory guidelines and data requirements for pesticide export. - Collect and coordinate information to prepare regulatory documentation for submission to regulatory agencies - To prepare a regulatory dossier on chemistry and residue, as per the company’s requirements and timelines. - To review PCP and other reports about...


  • Vadodara, Gujarat, India Krosyl Pharmaceuticals Full time

    **Regulatory Affairs Executive (01 Person)**: **Qualification**: B. Pharm / M. Pharm-RA **Experience**: 2 to 3 Years **Description**: - Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. - Well versed with the guidelines of ICH and other regulatory. - Preparation of documents for COPP, FSC,...

  • Regulatory Affairs

    3 weeks ago


    Vadodara, India Actide International Full time

    **Description**: - They must have excellent organizational, analytical, project management, and communication skills. - They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. - Most regulatory affairs positions are full time. - Regulatory Responsibility means a duty or responsibility,...