Officer / Sr Officer Regulatory Affairs US Post approval
1 week ago
Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle.
Good technical knowledge of regulatory submissions.
Strong knowledge of CTD /eCTD requirements for submission of dossiers.
Required Candidate profile
Handle activities assigned for in Regulatory Affairs department
1- 5 Years
B Pharm / M. Pharm
CMC documentation for US FDA submissions for Post approval supplements
Tracking labeling updates
-
Director Regulatory Affairs- US post approvals
2 weeks ago
Mumbai, Mumbai Suburban, Navi Mumbai, India Topgear Consultants Full time ₹ 12,00,000 - ₹ 36,00,000 per yearOpening with a leading Pharma company for their office in Navi MumbaiRole: Director Regulatory Affairs - US post approvalsExperience: 15 Years+Role & responsibilities :Essential Duties & Responsibilities:Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business...
-
Regulatory Affairs Officer
1 day ago
Mumbai, Maharashtra, India MEDVARSITY ONLINE LIMITED Full timeJob Title: Senior Executive - Regulatory Affairs UK/IE/MT Department: Regulatory Affairs Grade Level: P-2 Reports to: Manager / Sr. Manager - Regulatory Affairs Number of Reports: NONE Location: Mumbai **Main purpose of role**: To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio...
-
Regulatory Affairs Officer
7 days ago
Mumbai, India Agile Consultants Full time**Job Code**:047/001/753 **Location**:Mumbai **Salary**:Based on experience **Industry**:Chemical Manufacturing Our client is hiring an experienced Regulatory Affairs Officer who can provide guidance and support sites with the implementation of Raw Materials such as Lubricant Additives, Epoxy Paints & Coatings, Rubber/Carbon Black, Coating, Foam, and...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
-
Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...