![Actide international](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs
2 days ago
**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
-
Regulatory Affairs Assistant
2 weeks ago
Jarod, Vadodara, Gujarat, India Briyosis Soft Caps Pvt Ltd Full timeJob 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 Officer
2 months ago
Vadodara, Gujarat, India Vega Biotec Pvt. Ltd Full timeVega 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....
-
Regulatory Affairs Officer
14 hours ago
Vadodara, Gujarat, India Vega Biotec Pvt. Ltd Full timeVega 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....
-
Regulatory Affairs Executive
5 days ago
Vadodara, Gujarat, India Ronak Group Full timeLooking 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
3 months ago
Vadodara, Gujarat, India Ami Lifesciences Full time**Role & responsibilities** - EU Dossier preparation and submission to Europe market. - EU ASMF and CEP preparation and submission to Europe with post-approval activities - Handling of EDQM Agency Queries. - Brazilian DMF Preparation and Deficiency response. - China DMF Preparation and Deficiency response. - eCTD publishing in EDUCE software with PDF...
-
Regulatory Affairs Executive
4 weeks ago
Vadodara, India Amico Formulations LLP Full time**Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Vadodara - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents that include...
-
Regulatory Affairs Officer
4 weeks ago
Vadodara, India Vega Biotec Pvt. Ltd Full timeVega 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....
-
Regulatory Affairs
2 weeks ago
Ahmadabad, Gujarat, India Senores Pharmaceuticals Full timeDETAILS: Experience in regulatory affairs for ROW market EXPERIENCE: 2-3 years EDUCATION: B. Pharm/ M. Pharm LOCATION: Ahmedabad, India
-
Regulatory Affairs Executive
3 weeks ago
Navrangpura, Ahmedabad, Gujarat, India Bexcode Services Full time**Regulatory Affairs Executive Job Description** **Job Summary**: The Regulatory Affairs Executive will work with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements. **Duties/Responsibilities**: - Works in the regulatory affairs department on assigned projects. -...
-
Regulatory Affairs Executive
3 weeks ago
Vadodara, India Vega Biotec Pvt. Ltd Full timeVega 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 - Bsc. Chem/B.pharma/M.pharm Experience - 1 year minimum Job profile: 1. To assist manager...
-
Regulatory Affairs Executive
3 weeks ago
Science City, Ahmedabad, Gujarat, India Vetenza India Pvt Ltd. Full timeHiring 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 Officer
2 weeks ago
Science City, Ahmedabad, Gujarat, India Vetenza India Pvt Ltd. Full timeHiring for a **REGULATORY AFFAIRS OFFICER ** for our **Ahmedabad **location. Freshers with good knowledge should apply **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. -...
-
Regulatory Affairs Assistant
4 weeks ago
Vadodara, Gujarat, India Vega Biotec Pvt. Ltd Full timeVega 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 - Bsc. Chem/B.pharma/M.pharm Experience - 1 year minimum Job profile: 1. To assist manager...
-
Regulatory Affairs Officer
6 days 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
4 days ago
vadodara, India Vega Biotec Pvt Ltd Full timeVega 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.pharmaExperience- Minimum 4 years in RAJob Profile-1. CTD or ACTD dossier...
-
Regulatory Affairs Executive
2 weeks ago
Vadodara, Gujarat, India Vega Biotec Pvt Ltd Full timeVega 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.Senior Regulatory affairs executive-Qualification- Bsc/Msc Chem,Experience- Minimum 4 years in RAJob Profile-•CTD or ACTD dossier preparation for ROW...
-
Executive Regulatory Affairs
2 weeks ago
Vadodara, India Stellar Formulations Industries Pvt Ltd Full time1. Preparation, Review and Submission of the Dossiers as per CTD/ACTD guidelines as well a country specific guidelines. 2. Compilation of Dossiers and quality documents as per checklist in the guidelines. 3. Review of artworks as per the Regulatory requirements 4. Inter Department coordination to arrange and review of documents and samples for Regulatory...
-
Regulatory Affairs
4 days 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,...
-
Regulatory Affairs Associate
3 weeks ago
Vadodara, India Aakashkamal Enterprises Full timePosition Regulatory Affairs Associates Location - Vadodara KRA: As a RA Sr. Officer Reviewing artwork, PRAC variations, CEP updates for EU market. Preparation of Regulatory Strategic documents for EU/UK market. Review and compilation of deficiencies response for ROW (specially MENA, LATAM market) Compilation and submission of renewal, variation for...
-
Regulatory Affairs Executive
2 weeks ago
Vadodara, Gujarat, India Krosyl Pharmaceuticals Full timeRegulatory Affairs Executive (01 Person):Qualification: B. Pharm / M. Pharm-RAExperience: 2 to 3 YearsDescription: 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, and other legal documents...