Average salary: Rs394,285 /yearly
More statsSearch Results: 2,375 vacancies
Key Deliverables
Dossier review and complication of ANDAs for US Market.
Post approval for US
Document review i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.
Hands on Electronic Operation (eCTD...
...Responsibilities
Responsible for coordination & preparation of regulatory submissions and strategies.
Prepare and submit all the... ...Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US and Canada...
...ensure alignment with the Reference Listing Drug. This includes QC, proofing, editing and... ...proofreading tool TVT.
Work with US Regulatory Labeling Team to ensure assigned projects... ...experience, specifically in Regulatory Affairs with a focus on US Gx labeling
Knowledge...
...opportunities, support and rewards that will take you further.
Regulatory Compliance
As part of Global Risk, Regulatory Compliance... ...Role Purpose :
The role of the Vice President Regulatory Affairs involves following responsibilities:
Scan for legal and regulatory...
...the Annual Report schedule.
Retaining all supporting documentation as required in completing an Annual Report.
Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late.
Decision Making:...
...database records pertaining to approved products in line with systems, processes and procedures.
Leading and/or coordinating regulatory affairs projects, as assigned.
Preparation of submission and approval notifications for applications submitted to Regulatory agencies...
...Organization for PE and BE studies.
Coordination with ANVISA for technical queries
Desired Skills
Complete knowledge of ANVISA regulatory guidance
Proficient in new product submissions for solid oral dosages, parental/sterile formulations to ANVISA
Reading/Writing...
...We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.
Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory Affairs
Experience: 3 to 9 years
Location: Andheri...
...event in Delhi 2022.
Responsibilities
Support in creating regulatory and quality policy plan as needed internally and externally
Work... ...Requirement
Good understanding of the latest regulatory affairs
Ability to quickly prioritize and execute tasks
Strong analytical...
...Lead consultant, Regulatory Affairs Pharmaceutical - LIF016391
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility...
Pharmaceutical manufacturing company at Andheri East, Mumbai, having a vacancy for Regulatory Affairs.
B.Sc/B Pharma and should have experience as Regulatory Affairs in Pharma company
Job Profile: Regulatory Affairs & Compliance of Pharma company
Preparing dossiers...
...Lead consultant, Regulatory Affairs Pharmaceutical - LIF016236
With a startup spirit and 115,000 + curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the...
...The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical research organization. This position will play a crucial role in ensuring compliance with regulatory requirements and providing...
Rs 2.2 - 2.8 lakhs p.a.
...checking and follow-up
Re-registration Dossier
Registration / Submission certificates updation
Translation files record
Regulatory Affair,Formulation,Pharmaceutical
Designation: Executive - Regulatory Affairs
Vacancies: 1
Experience: 1.0 Year(s) - 2.0 Year(s...
...Responsibilities
Support in creating regulatory and quality policy plan as needed internally and externally
Work with internal personnel... ...to the candidate with 3+ years experience in regulatory affairs
Ability to quickly prioritize and execute tasks
Experience...
...colleague Assistant Manager responsible for the regulatory activities both (Operational & Strategy)... ...related to assigned portfolio like new drug applications , Form 41 & Form 45... ...Interaction: Government Health Authority, BoH, etc. ,
Regulatory Affairs
#LI-PFE
...regulations.
To liaise with stakeholders to identify forthcoming regulatory challenges and proactively seek expert input to resolve issues... ...engagement.
Highly motivated and experienced regulatory affairs professional
Comfortable working with different cultures and...
...implementation of the change.
Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the... ...you
Experience : (8-12 years of experience in Regulatory Affairs, Quality Assurance)
Soft skills : Transversal skills, Stakeholders...
Rs 2.4 - 4.2 lakhs p.a.
...complex activities, often with competing priorities.
Most regulatory affairs positions are full time.
Regulatory Responsibility means... ...market mainly African, Latin & Central American Countries
Drug Regulatory Affair,dossier preparation ,ECTD,ACTD
Designation...
...we are embarking on an exciting journey to expand our reach globally.
Role and Responsibilities:
We are seeking a Manager Regulatory Affairs to join our team. In this role you will be responsible for supporting the creation of regulatory and quality policies both internally...
