Average salary: Rs1,300,000 /yearly
More statsSearch Results: 3,088 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...
...About the role:
Reporting to the Head of Regulatory Affairs you will be a key member of the team which is responsible for providing strategic and operational regulatory support to project management on new divestment projects technical transfer CMOs quality assurance and...
...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:...
...We at Navi Mumbai International Airport looking for Regulatory Affairs expert for to fill the critical slot of Lead Regulatory Affairs & Business Support position. The position is based out of Navi Mumbai. The position Lead Regulatory and Business Support Services is responsible...
...ensure the timely submission of the labels to health authority.
Job Responsibilities
Responsible for coordination & preparation of regulatory submissions and strategies.
Prepare and submit all the supporting documents for labelling submissions as per the type of...
...Position Overview:
~ Handling assigned activities in the regulatory department.
Experience:
~5-8 years
Qualification:
~ B. Pharm, M.Pharm preferred.
Responsibilities:
Compilation of ANDA submissions in accordance with the latest guidances...
...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...
...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...
...utilizing the electronic proofreading tool TVT.
Work with US Regulatory Labeling Team to ensure assigned projects like RLD updates, Safety... ...(Pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling
Knowledge and Skills...
...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...
...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...
