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...digital operations services, and expertise in data, technology, and AI.
Inviting applications for the role of Lead Consultant Regulatory Affairs, CMC and labelling for Dubai market
In this role Candidate should have experience in regulatory affairs while essential...
...firepower.
Welcome to the relentless pursuit of better.
Inviting applications for the role of a Lead consultant, Regulatory Affairs Pharmaceutical
You should have minimum years of experience in regulatory affairs with must knowledge of current regulatory guideline...
QUALIFICATIONS:-
B.PHARMA / M.PHARMA
PHARMA REGULATORY
Skills
Analytical
~ Time management
Presentation skills .
Interpersonal... ....
Experience-- 4-5 Years of Experience in Pharma Regulatory Affairs
Job Summary
Core understanding of technical requirements...
...documentation as required in completing an Annual Report.
Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an... ...(s)
Experience:
Five to Six year experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D,...
...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... ...five years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organization are likely to...
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...
...electronic proofreading tool TVT.
Work with US Regulatory Labeling Team to ensure assigned projects like... ...Relevant years of experience: 4 plus years (Pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling
Knowledge and...
...for Good Manufacturing Practices to ANVISA
Coordination of Pharmaceutical and Analytical Testing laboratory and Clinical Research Organization... ...queries
Desired Skills
Complete knowledge of ANVISA regulatory guidance
Proficient in new product submissions for solid...
...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...
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...
...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...
...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...
...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...
...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...
Rs 2.2 - 2.8 lakhs p.a.
...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)
Telephonic...
...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...
...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...
...colleague Assistant Manager responsible for the regulatory activities both (Operational & Strategy)... ...or post-graduate degree in Pharmacy, Pharmaceutical Medicine, Pharmacology, or any other... ...: Government Health Authority, BoH, etc. ,
Regulatory Affairs
#LI-PFE
...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...