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...
...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...
...Responsibilities
Support in creating regulatory and quality policy plan as needed internally... ...understanding of the latest regulatory affairs
Ability to quickly prioritize and... ...Strong documentation skills
regulatory affairs,document review,medical devices,documentation...
...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...
...Responsibilities
Support in creating regulatory and quality policy plan as needed internally... ...candidate with 3+ years experience in regulatory affairs
Ability to quickly prioritize and execute tasks
Experience in medical devices
Strong analytical skills and attention...
...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...
...proofreading tool TVT.
Work with US Regulatory Labeling Team to ensure assigned projects... ..., Annual reportable changes, Electronic Medication Guide initiatives etc. and any other projects... ...experience, specifically in Regulatory Affairs with a focus on US Gx labeling...
....
Role and Responsibilities:
We are seeking a Manager Regulatory Affairs to join our team. In this role you will be responsible for supporting... ...to quickly prioritize and execute tasks
Experience in medical devices
Strong analytical skills
Attention to detail
Strong...
...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...
...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...
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...
...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...
...Job Title: Manager -Medical Affairs
Department: Medical Affairs
Location: Kandivali (West), Mumbai
Qualification & Experience:
· MD Pharmacology with 1year experience in medico-marketing.
Key Responsibilities:
· Scientific support for New Product launches...
...Position :Sales Associate Medical Device Experience : 2 years+
CTC : Based on current ctc + incentives
No of Vacancies : 3
Location... ...understanding of medical devices, healthcare industry dynamics, and regulatory requirements.
• Demonstrated track record of achieving sales...
...intellectual 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...
...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)... ...Internal Interaction: Commercial, Medical, Above Country Colleagues, RRL, HSM, HLM,... ...Interaction: Government Health Authority, BoH, etc. ,
Regulatory Affairs
#LI-PFE
...The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical... ...teams, including Clinical Operations, Quality Assurance, and Medical Affairs, to ensure regulatory compliance and timely execution...
...documentation as required in completing an Annual Report.
Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual... ..., race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression,...
...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...
...As a Medical Affairs professional, you will contribute actively to devise and implement the medical affairs strategy, be a specialist in the... ...original research and review article.
Work in Clinical Trials, Regulatory Affairs, Pharmacovigilance etc.
Involves coordination with...
Process:- Medical Billing
Hiring for Medical Billing
Profile:- AR caller
Location:- Mulund
Education:- Graduate Fresher and Experience can apply.
Shift:- US shift 24/7 (9 hours login)
Salary:- 15k - 21k
Week off:- 5 days working 2 rotational weekoff
Need...
...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...
Rs 2.4 - 4.2 lakhs p.a.
...work frequently with other employees and team members to coordinate complex activities, often with competing priorities.
Most regulatory affairs positions are full time.
Regulatory Responsibility means a duty or responsibility, assigned to an individual by...
...Job Description :
Job Title:
Ideation Specialist (Medical Affairs)
Job Category:
Head Office Based Medical Affairs... ...Board Members of Scientific Societies, Consultancy agencies, Regulatory authorities and other stakeholders
Internal Stakeholders...
...intellectual firepower.
Welcome to the relentless pursuit of better.
Inviting applications for the role of Lead Consultant Regulatory Affairs, CMC for UAE markets.
In this role Candidate should have experience in regulatory affairs while essential exposure to the...
...Manger Regulatory Affairs, Labelling for USA market - LIF014460
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, and reinvent the ways companies...
...- We are seeking a Business Executive (Institutional sales or government sales) for a medical equipment manufacturing organization Job Title : Business Executive (Institutional Business) Locations : Chandigarh ,Guwahati , Mumbai , Hyderabad Target Products : patientmonitor...
...Lead Consultant Regulatory Affairs, Labelling and Safety portfolio - LIF013726
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, and reinvent...
...associated with this role.
Execute all regulatory activities in accordance with corporate... ...to support local and global regulatory affairs.
Supports regulatory information management... ..., Quality or Compliance team in a medical device, pharmaceutical, cosmetic, or similar company...