...compliance, MDSAP compliance and supplier audits. We help organizations improve their operations and meet regulatory standards through our expertise in regulatory affairs and project management. Our company is based in Mumbai, Maharashtra, India.
Role Description
This...
Rs 5 - 6 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...
...We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team.
Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory Affairs
Experience: 3 to 9 years
Location:...
...Dear Candidates
Greetings from Randstad India !
We have an opening for the role of Executive Regulatory Affairs with a leading pharma company in India.
Interested candidates can drop your resume to the mail id
The details are below:
Qualification...
...being – a fundamental driver for many of us to show up and do our best each day.
Job Description
You will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics...
...Everyone at Halma India makes an impact, and so do you when you join us!
Responsibilities:
Have regular meetings with international Regulatory Teams of Halma Companies to understand their evolving business needs wrt Indian market.
Assist them in understanding the India...
...Regulatory Affairs Specialist
Responsibilities:
Prepare and submit regulatory documentation for new and existing medical products, including drugs, devices, and biologics.
Stay up-to-date on ever-evolving regulatory requirements and guidelines.
Liaise with regulatory...
...Description
Coordinate with cross-functional teams to implement regulatory initiatives and quality improvement projects.
Manage the... ...Coordination: Collaborate with internal departments such as regulatory affairs, legal, compliance, quality assurance, and clinical operations...
Rs 10 - 15 lakhs p.a.
...product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US)
-Hand on experience in... ...hand Ons experience for handling of E-CTD software
Regulatory Affair,RA
Designation: Regulatory Affairs - Pharma
Vacancies: 1...
...products and services to customers worldwide.
Position Overview: We are seeking a highly skilled and experienced Vice President Regulatory affairs to lead our Regulatory department and contribute to the strategic growth of organization. The ideal candidate will have a PHD in...
...Job Description
Job Title: Regulatory Affairs Director
Career Level - F
Introduction to Role: Are you ready to apply your Regulatory Affairs strategy expertise to make a real difference? At AstraZeneca, we follow the science and turn ideas into life changing medicines...
Rs 3 - 5 lakhs p.a.
...develop product trials and interpret trial data
advise scientists and manufacturers on regulatory requirements
provide strategic advice to senior... ...advertising before a product's release.
Regulatory Affairs,Regulatory Compliance,marketing Authorisation
Designation...
RA US injectable JD:
Knowledge on manufacture and testing of sterile products and Knowledge of environmental conditions during sterile product manufacturing.
Review and clearance of pre-exhibit batch R&D documents like formula clearance w.r.t Q1/Q2, IIG, specifications...
...Qualification - Energy studies – any field
Competencies / Key Skills Required -
1. Research competencies including writing skills for regulatory submissions to nodal agencies
2. Strong technical and analytical skills
3. Strong written and oral communication skills...
...that Change Lives
Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations.Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. Responsible for...
...the global paints, coatings and inks market, Eastman is looking for a highly motivated individual to join the Product Steward & Regulatory Affairs (PSRA) team. The Product Steward Representative is the key link between the business and technology partners, and the larger Global...
...pharmaceutical companies.
Position purpose
For assigned products: Regulatory Acceleration process Plan to gain rapid and high-quality... ...Internal customers
Marketing, Sales, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand...
$ 70000 p.a.
...ll meet these challenges. Join us!
The Senior Director, Regulatory Affairs is a leader, who provides vision and direction in a fast-paced... ..., and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment...
Rs 3 - 5.5 lakhs p.a.
...Description :
Regulatory Compliance:
Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking... .../M.Pharma or Biomedical Engineering or Diploma in Regulator Affairs, Quality Management System.
~3-5 years of experience in Quality...
...Topline:
Documentation of Regulatory product Dossiers, Compliance implementation within different verticals with Process and training
Regulatory Auditing skills for the compliance process strengthening
Legislative aspect of Regulations forming and designing
Advocacy...
#ROW MARKET #CIS #MENA #AFRICA #LATIN #ASIA #EUROPE MARKET
Vacancy - 15
Qualification - B.Pharm/M.Pharm
Job Description :
Sound knowledge of CTD/ECTD/ACTD dossier review of OSD/Parenteral dosage forms.
Excellent knowledge of ICH/Country specific/Variation...
...Medical Device Regulatory Affairs Job duties of a Regulatory Affairs Specialist include:
Developing and implementing regulatory strategies for new and existing products
Preparing and submitting regulatory documentation to regulatory authorities
Liaising with regulatory...
...difference, and new people to make a difference with.
The opportunity
This is a critical and senior position within the global regulatory affairs team at Teva. In this multifaceted role, the incumbent will interface with the business, with other R&D functions, as well as...
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...
...GP, Ecosprin AV, Jalra, Tazloc, Glynase and more.
Responsibilities:
For the CMC RA position: Biosimilar Product Development Regulatory support – CMC
For the Clinical RA position Biosimilar Product Development Regulatory support - Clinical
Biosimilar Regulated market...
...We are hiring for dynamic individuals in Regulatory Affairs Department:
Experience: 3 years up to 12 years
Designation: Senior Exec / Assistant Manager / Deputy Manager
Qualification: M. Sc. / M. Pharma/ B. Pharma
For Below Mentioned roles: -
Role 1: - API...
...About the job
We are looking for an experienced Regulatory Affairs Specialist to join our growing team to assist CMR Senior Regulatory Affairs Specialist (AMEA) in all tasks relating to registrations for new or modified product. We are advertising this role to be based in...
...safer, sustainable and more connected world.
Job Overview
Regulatory Affairs oversees compliance activities for customers. This covers... ...products.
Responsibilities:
• Support daily Regulatory Affairs function eg; compliance to 21 CFR 820,807,803 ISO 13485...
Rs 2.5 - 6.5 lakhs p.a.
...the work progress to your line manager in 1:1 in weekly/ monthly meetings and other stakeholders appropriately as and when advised
Regulatory,R&D,Drug Regulatory Affair
Designation: Data Scientist - Regulatory
Vacancies: 1
Experience: 1.0 Year(s) - 7.0 Year(s)...
About the job
Key Accountabilities:
Project Execution:
Works effectively within a team environment
Works within broad project guidelines as directed by the Project Lead or Technical SME
With the guidance of the project Technical SME demonstrates the ability to...