No longer accepting applications
Regulatory Affairs Associate I
Teva Pharmaceuticalsgandhinagar, gujarat, in22 days ago
Job descriptionResponsible for executing GRO Regulatory Data Analytics operations in line with Work Instructions and SOPs. Primarily will be Regulatory Data Analytics Service related to product registration data management (includes the procurement of data from source regulatory documentation which requires a thorough understanding of the structure and contents of a regulatory dossier, and a thorough understanding of the data structures applicable to registration data and the related system workflows). Operationally hands-on in terms of carrying out data management activities as an individual contributor. This will require a thorough understanding of the structure and contents of a regulatory dossier (i.e. will be fluent in navigating and understanding the contents of a dossier). Registration data management will require a thorough understanding of the registration data structures, workflows, and applicable work instructions etc. Perform Quality Control (QC) and data integrity checking, as part of the Regulatory Data Analytics operation, to confirm the accuracy and completeness of the Teva Global Registration database. Represent GRO Regulatory Data Analytics across the wider Global Regulatory Affairs community. Must be proficient at building effective working relationships with all stakeholder and customer groups. Responsible for providing effective business project contributions for projects focused on improving regulatory data quality, the provisioning of regulatory data for internal re-use via system integration, or the implementation of any business or technology change that impacts regulatory data or the regulatory technology landscape. B Pharm / M Pharm only 1-3 years (Preferred relevant experience in regulatory operations / affairs only) Experience of the pharmaceutical industry with direct experience in Regulatory Affairs, possessing a solid understanding of the pharmaceutical regulatory affairs process. Experience of managing regulatory product registration data, ideally within a regulatory information management environment.
Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics)
Primary purpose of the role :
The role of GRO Regulatory Data Analytics is to :
- Manage Teva’s data in accordance with requirements for xEVPMD in order to maintain Teva’s Article 57 compliance
- Provide a Central Data Service for the creation and maintenance of GRA product registration data in line with the global needs of Teva Global Regulatory Affairs.
- Provide SME services for data management in current and future regulatory data systems
The primary purpose of this position is to execute the operations and services applicable to the GRO Regulatory Data Analytics role in line with business goals and objectives.
Main Duties & responsibilities :
Qualification & Experience :
Best regards
Ankita
Create a job alert for this search
Associate • gandhinagar, gujarat, in
Related jobs
- Promoted
Regulatory Affairs Associate I
Teva PharmaceuticalsGandhinagar, Gujarat, India Role : Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics) Primary purpose of the role : The role of GRO Regulatory Data Analytics is to : Manage Teva’s data in accordan...Show moreLast updated: 22 days ago
- Promoted
- New!
Regulatory Affairs Specialist
Dr. Reddy's Laboratoriesahmedabad, India We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for thes...Show moreLast updated: 16 hours ago
- Promoted
Executive - Regulatory Affairs
ConfidentialAhmedabad Preparation of Financial Models for Tariff Petitions.Drafting of Tariff Petitions, Replying to queries of GERC / JERC / CERC related to Tariff Petitions.
Analysis of Miscellaneous Petitions / Orders of di...Show moreLast updated: 30+ days ago
- Promoted
Senior Executive, Regulatory Affairs, Pre Approval Injectable USA Market
ConfidentialAhmedabad, India Your Responsibilities Include, But Are Not Limited To.Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc.O...Show moreLast updated: 4 days ago
- Promoted
Research Associate
Cadila Pharmaceuticals LimitedAhmedabad, Gujarat, India Core responsibility related to GLP Study Director.Approve the study plan and any amendments to the study plan by dated signature.
Make the study plan available to RQA for verifying that it contains ...Show moreLast updated: 22 days ago
- Promoted
Regulatory Affairs Specialist – Medical Devices
ConfidentialAhmedabad Alpine Health is a licensed pharmaceutical distributor based in Secaucus, New Jersey, USA.Alpine Health offers a full range of generics,OTC's, diabetic supplies, vials and nutritional milk.The orga...Show moreLast updated: 30+ days ago
- Promoted
Senior Executive, Regulatory Affairs (US Injectable-Pre Approval)
ConfidentialAhmedabad, India Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possib...Show moreLast updated: 4 days ago
- Promoted
Senior Manager - Regulatory Affairs
ConfidentialAhmedabad, India Intas Pharmaceuticals does not request or accept any fees during recruitment.If someone asks for payment on our behalf, it is a scam.
Please report the incident to the local police or cybercrime uni...Show moreLast updated: 4 days ago
- Promoted
Senior Associate-Indirect Tax
BDO Indiaahmedabad, gujarat, in We assist businesses in Indirect Tax advisory, compliances, transaction structuring, health check and refund related assignments We also assist in review and optimization of input tax credit, recon...Show moreLast updated: 9 days ago
- Promoted
Regulatory Affairs Officer
A.P. Moller - MaerskGandhinagar, Gujarat, India Moller - Maersk is an integrated container logistics company working to connect and simplify its customers’ supply chains.
As the global leader in shipping services, the company operates in 130 coun...Show moreLast updated: 30+ days ago
- Promoted
Assistant Manager Regulatory Affairs
Biotech HealthcareAhmedabad, Republic Of India, IN Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements.
The role ensures timely preparation ...Show moreLast updated: 1 day ago
- Promoted
Assistant Manager Regulatory affairs
ConfidentialAhmedabad, India Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements.
The role ensures timely preparation ...Show moreLast updated: 3 days ago
- Promoted
Senior Associate, Pharma Commercial Operations
KMK Consulting Inc.Gandhinagar, IN KMK is a global data analytics and technology consulting company empowering leaders across the Life Sciences industries to make better data-driven decisions.
Our data analytics and software platform...Show moreLast updated: 30+ days ago
- Promoted
Senior Associate Director - Public Relations
EmeritusGandhinagar, 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: 1 day ago
- Promoted
Senior Regulatory Affairs Executive
ConfidentialAhmedabad, India Dossier Preparation & Compilation : Lead and oversee the preparation, review, and submission of.CTD, ACTD, and eCTD formats for global markets, ensuring compliance with.
Regulatory Strategy & Market ...Show moreLast updated: 4 days ago
- Promoted
Manager / Senior Manager Engineering (Industrial Cylinders)
Bosch Rexroth IndiaSanand, Gujarat, India Engineering Industrial Cylinder System.Plan and align departmental engineering goals with broader business objectives, ensuring that engineering contributions are aligned with long term strategic v...Show moreLast updated: 1 day ago
- Promoted
Assistant Manager Regulatory affairs
Biotech HealthcareAhmedabad, Gujarat, India Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements.
The role ensures timely preparation ...Show moreLast updated: 1 day ago
- Promoted
Associate - Revenue Operations
EmeritusGandhinagar, IN Emeritus has partnered with more than 30 universities to date, including MIT, Columbia, Harvard, Cambridge, INSEAD, Wharton, UC Berkeley, INCAE, IIT, IIM, NUS, and HKUST, launching more than 100 co...Show moreLast updated: 22 days ago