This job offer is not available in your country.
Sr. Executive / Assist. Manager / Dy. Manager - Regulatory Affairs
ConfidentialVadodara12 days ago
Job descriptionCompilation and review of product license applications, variations, and renewals for Mexico country as per regulatory requirements respectively with minimal supervision Manages electronic documents and creates electronic submissions in CTD format. Preparation and review of responses to authority questions during registration and product lifecycle. Keep track of assigned projects and follow-ups to ensure the Dossier is delivered as per set timeline / commitments. Designing, Reviewing & Approval of Artwork required for registration purposes. Dossier due diligence for products being in-licensed from other company Support in preparing the meeting materials as needed, eg, regulatory project status / submission / approval information monthly, quarterly or yearly.
Job Criteria :
- B.Pharm or M.Pharm qualification having experience between 7 - 15 yrs. with dossier filling experience in MEXICO or South East Asian Countries.
- Knowledge for review of quality documents like executed batch documents, method validation, change
- Good communication skill
Job Responsibility :
Skills Required
Drug Regulatory Affairs, Regulatory Affairs, dossier preparation
Create a job alert for this search
Sr Manager • Vadodara
Related jobs
)
- Promoted
Head of AI Powered SaaS Product / Regulatory SME
ComplyLensNadiad, IN Hybrid (India-based with remote work flexibility).Please only apply if you have experience of working in Capital Markets and with financial regulations.
Are you a dynamic, action-oriented individual...Show moreLast updated: 5 days ago
- Promoted
Project Manger - Pharma
RED GlobalAnand, IN Project Manger - Pharma - Remote - 12 month contract, extendable.The Project Manager will lead the delivery of SAP S / 4HANA initiatives within a pharmaceutical environment, ensuring alignment with b...Show moreLast updated: 30+ days ago
- Promoted
Assistant Manager - CRM Operations
EmeritusNadiad, IN Emeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world.It does this by col...Show moreLast updated: 30+ days ago
- Promoted
Assistant Vice President – Practice SME-Agentic AI!
GenpactAnand, IN Ready to build the future with AI?.At Genpact, we don’t just keep up with technology—we set the pace.AI and digital innovation are redefining industries, and we’re leading the charge.If you thrive ...Show moreLast updated: 23 days ago
- Promoted
Assistant Design Manager
Naman StaffingHalol, Gujarat, India One of the leading names MNC into Switchgear Manufacturing.Exp-8+ Years’ experience in Design into customer specification.
Job location- Halol near Vadodara, Gujarat.Understanding of Customer requir...Show moreLast updated: 7 days ago
- Promoted
Associate Manager Taxation (Direct & Indirect)
CollaberaVadodara, Gujarat, India We are seeking a highly skilled and detail-oriented Lead / Asst.Manager – Taxation to lead and manage the organization’s tax function.
The ideal candidate will be responsible for compliance with dir...Show moreLast updated: 25 days ago
- Promoted
Manager IT - MES SME
SUN PHARMAHalol, Gujarat, India We are having an opening for Manager IT - MES SME at our Halol or Baska(Gujarat) location.We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, includi...Show moreLast updated: 30+ days ago
- Promoted
Sr. Manager / Manager PPIC
Aarti Pharmalabs Ltd. (APL)Anand, IN Familiar with IT skills such as Microsoft excel, powerpoint ,Google drive.Good knowledge of mapping of reactors.Process flow diagram preparation.
Good knowledge of production planning scheduling bas...Show moreLast updated: 26 days ago
- Promoted
Editorial Review Manager
JoVENadiad, IN JoVE is the world- leading producer and provider of video solutions with the mission to improve scientific research and education.
Millions of scientists, educators and students use JoVE for their r...Show moreLast updated: 30+ days ago
- Promoted
Assistant Manager
TessolveNadiad, IN Position : Design Verification- Manager Engineering.Experience : 12+ years relevant experience.Location - Bangalore / Hyderabad / Chennai / Noida.
To be successful in this role you will : .Seeking highly moti...Show moreLast updated: 4 days ago
- Promoted
Senior Project Manager
Zensar TechnologiesNadiad, IN Job Role- Senior Project Manager.Primary Skills- Strong experience with CISCO Products, CCW and CCWR, EA(Enterprise Agreement), Project Manager role.
Lead and manage Cisco Commerce projects from ini...Show moreLast updated: 6 days ago
- Promoted
Manager / Sr.Manager - Global Quality Sustainability, Training and Quality Culture
SUN PHARMAVadodara, Gujarat, India Manager - Global Quality Sustainability, Training and Quality Culture.Setting up baseline data for sustainability projects and Quality Cultural from various SUN sites.
Assessment, interpretation and...Show moreLast updated: 3 days ago
- Promoted
Market Access Manager
vueverse.Vadodara, IN We are seeking an experienced and strategic.The role requires strong cross-functional collaboration with Commercial, Medical Affairs, Regulatory, and Health Economics teams to develop and execute m...Show moreLast updated: 18 days ago
- Promoted
BLA Regulatory Publishing Specialist – Veeva eCTD
vueverse.Anand, IN BLA (Biologics License Application).Compile, format, and publish regulatory documents according to global health authority requirements.
Ensure compliance with regulatory guidelines (FDA, EMA) and i...Show moreLast updated: 20 days ago
- Promoted
Senior Manager - Strategic Partnership
GEDU ServicesVadodara, IN Partnership Development & Management.Identify, initiate, and formalize partnerships with Indian colleges and universities.
Negotiate MoUs and articulation agreements for student progression, twinnin...Show moreLast updated: 30+ days ago
- Promoted
Senior Manager - Research and Proposals
impactDashNadiad, IN Senior Manager – Research & Proposal Management.LPA – ₹15 LPA (commensurate with experience).The Manager – Research & Proposal Management will lead the end-to-end development and delivery of high-i...Show moreLast updated: 6 days ago
- Promoted
Manager - Quality Control (Agrochemical)
ScimplifyHalol, Gujarat, India We are a specialty chemicals manufacturing company with a full stack solution from R&D to manufacturing and doorstep delivery of innovative chemicals.
Headquartered in Bengaluru, India we cater to p...Show moreLast updated: 7 days ago
- Promoted
Lead Regional Compliance Specialist
Securitas GroupAnand, IN Lead Regional Compliance Specialist - APAC.India – open to Chennai / Hyderabad / Pune.We are a dynamic, dedicated team that provides management and support for a global guarding services account that s...Show moreLast updated: 25 days ago