Required Drug Regulatory Affairs
7 days ago
Company Name: Exemed Pharmaceuticals
Designation - Drug Regulatory Affairs -Officer/Sr Officer
Location - Vadodara ( Corporate Office)
Market: Domestic
Primary Job Descriptions
- Having knowledge of SUGAM portal and CDSCO website
- Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC.
- Application of CT-05 / CT- 04
- Application of CT-10 / 12/ 13
- Application of import Licenses [CT-16/ Form 12/Form 08]
- Knowledge of IPC submissions
- Form 29 application
- Preparation of presentation for Subject Expert committee (SEC)
- Product Lifecycle & Management
Additionally, should be well verse with
- Preparation of Module 4 & 5 Nonclinical & Clinical data
- Preparation of Pack Insert (PI), Patient information leaflet (PIL) and Summary Product Characteristics (SPC)
- Literature Search (Nonclinical, Clinical, Formulation etc.)
- Preparation of Product Monograph
- Preparation of different types of rationales (for FDC, efficacy, dosing etc.)
- Aware of BABE Guidelines/ CT Phase III guidelines & Animal Toxicology
-
Executive Regulatory Affairs
2 weeks ago
Vadodara, Gujarat, India Exemed Full time ₹ 4,00,000 - ₹ 12,00,000 per yearResponsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.Responsible for prepare and review...
-
Regulatory Affairs Specialist
2 weeks ago
Vadodara, Gujarat, India Ami Lifesciences Full time ₹ 6,00,000 - ₹ 12,00,000 per yearRole & responsibilitiesResponsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries.Review and submission of Response to queries raised on DMF by USFDA, and other agencies.Review and submission of Amendments and revisions of Drug Master Files.Review and ensuring the...
-
Regulatory Affairs Executive
2 weeks ago
Vadodara, Gujarat, India Amico Formulations LLP Full time ₹ 2,50,000 - ₹ 3,00,000 per yearPOST: RA OFFICER/EXECUITVELOCATION: JAROD, VADODARAEXPERIENCE: 2-3 YEARSExperience in handling regulatory affairs for ROW market mainly Latin American, African & Asian countries for Pharma Formulations.Preparation, compilation & Review of Registration documents that include Administrative & Technical.Reviewing the technical documents provided by QA, QC,...
-
Executive - Regulatory Affairs
1 week ago
Vadodara, Gujarat, India SUN PHARMA Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob TitleExecutive – Regulatory AffairsBusiness UnitR&D1 Regulatory AffairsJob GradeG12ALocationBarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As you enter the Sun...
-
Regulatory Affairs Specialist
7 days ago
Vadodara, Gujarat, India Flax Laboratories Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPreparation of DMFs for different markets in CTD and eCTD formats.Coordination with cross-functional dept to manage the documents.Supporting marketing team & QC/QA/R&D in various capacity.Preparation of Declarations and other supporting docs. Required Candidate profileCandidate from Pharma - API industry and should have 8+ Years of Experience in Regulatory...
-
Regulatory Affairs Officer
7 days ago
Vadodara, Gujarat, India Asoj Soft Caps Full time ₹ 1,20,000 - ₹ 1,80,000 per yearResponsibilitiesAs a regulatory affairs officer:ensure that a company's products comply with the regulations of the regions where they want to distribute themkeep up to date with national and international legislation, guidelines and customer practicesrespond to queries from medical bodies like the Medicines and Pertaining to that Guidelines.collect, collate...
-
Executive - Regulatory & Business Continuity
7 days ago
Vadodara, Gujarat, India SUN PHARMA Full time ₹ 15,00,000 - ₹ 25,00,000 per yearJob TitleSenior Executive /Manager 2 – Regulatory AffairsBusiness UnitR&D1 Regulatory AffairsJob GradeG11A/G11BLocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own...
-
Regulatory Affairs Manager
1 week ago
Vadodara, Gujarat, India Flax Laboratories Private Limited Full time ₹ 6,00,000 - ₹ 8,00,000 per yearPreparation of DMFs for different markets in CTD and eCTD formats.Coordination with cross-functional dept to manage the documents.Supporting marketing team & QC/QA/R&D in various capacity.Preparation of Declarations and other supporting docs.Job Types: Full-time, PermanentPay: ₹600, ₹800,000.00 per yearBenefits:Food providedHealth insuranceProvident...
-
Executive - RA
5 days ago
Vadodara, Gujarat, India SUN PHARMA Full time ₹ 15,00,000 - ₹ 25,00,000 per yearJob TitleExecutive – Regulatory and Business ContinuityBusiness UnitR&D1 Regulatory AffairsJob GradeG12ALocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As...
-
Sr. Executive
4 days ago
Vadodara, Gujarat, India SUN PHARMA Full time ₹ 12,00,000 - ₹ 24,00,000 per yearJob TitleExecutive- Regulatory & Business ContinuityBusiness UnitR&D1 Regulatory AffairsJob GradeG12ALocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own Sunshine? As you...