Average salary: Rs3,045,000 /yearly
More stats ...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...
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...
...MNRE, MoP, state energy development authorities, solar and wind associations)
7. Tracking of state and central level tariff notifications... ...-
1. Research competencies including writing skills for regulatory submissions to nodal agencies
2. Strong technical and analytical...
...Associate Manager, Regulatory Affairs (CMC)
at ClinChoice (View all jobs)
Bangalore or Hyderabad - India
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative...
...with cross-functional teams to implement regulatory initiatives and quality improvement... ...internal departments such as regulatory affairs, legal, compliance, quality assurance, and... ...authorities, government officials, industry associations, and advocacy groups. Collaborate with...
Rs 3 lakh p.a.
...Analytical method validation review as per the ICH guideline.
- Drug Master File review
- Technical query response to the various regulatory authorities.
Ideal Profile
~ You have at least 1 year post-qualification experience in a similar role.
What's on Offer?...
...Title/Designation: Senior Regulatory Executive Based at: Ahmedabad
Industry: Medical Devices... ...in the Quality Assurance / Regulatory affairs, in the field of class III / class D... ...Identifies and assesses regulatory risks associated with assigned projects and timely communication...
...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:...
...a highly motivated individual to join the Product Steward & Regulatory Affairs (PSRA) team. The Product Steward Representative is the key link... ...Product Stewardship & Regulatory Affairs colleagues, Trade Associations and/or NGOs.
• Project leadership: Develop AP regional...
...Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations.Supports the Global Operating Unit Regulatory Affairs function as the local representative... ...pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned...
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...
...• First Class B.Pharm with Masters degree in Pharmaceutical Regulatory Affairs / Pharmaceutics.
• Registration as a pharmacist under the Pharmacy... ..., industry and/or profession in which 5 years must be Associate Professor in PCI approved/recognized Pharmacy college.
• Experience...
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Mumbai
1 day ago
...competent and experienced people to join in our growth journey.
Role Description
This is a full-time on-site role as a Regulatory Affairs Manager at Medico Remedies Ltd. located in Andheri, Mumbai. As a Regulatory Affairs Manager, you will be responsible for ensuring...
...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...
...Position : Executive Department : Regulatory Affairs
Location : Kandivali - West, Mumbai
Qualification - M Sc/ B Pharm/ M Pharm
Experience : 4 - 8 years and above
Role
Responsible for activities related to own submission and support for contract manufacturing...
...Position purpose
For assigned products: Regulatory Acceleration process Plan to gain rapid... ..., Sales, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams... ...Government Agencies, Manufacturers, Local Trade Associations, Legal Professionals
Minimum...
...where your purpose accelerates our mission.
Create and Review regulatory documentation for Drug, Device and Combination product renewals.... ...Ability to contribute to multiple projects from a regulatory affairs perspective
Ability to multitask and prioritize
Interpersonal...
...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...
...Africa.
They are head quatered in Europe, having repacking unit in Gandhidham and Corporate office in Ahmedabad
Position : Regulatory Affairs Officer
Job Location : Bodakdev (Ahmedabad)
Reports To ; Regulatory Manager
Job Profile:
The position would...
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...
...day
Evaluate dossier suitability for specific territories.
Regulatory strategize, prepare and submit MAAs to Medis clients.
Engage... ...Msc in chemistry.
~12 to 18 years of experience in Regulatory Affairs
~ Expertise in global regulatory strategies.
~ Strong skills...
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...
...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...
#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...
...Job description
The Director of Regulatory Affairs at DELFI Diagnostics will support the representation of DELFI with the FDA and other US and international regulatory agencies. Internally, this role will support and direct the regulatory function, regulatory activities...
...Topline:
Documentation of Regulatory product Dossiers, Compliance implementation within different verticals with Process and training... ...Regulations forming and designing
Advocacy -Partnering with Industry association for Industry agenda
Role and Responsibilities:...
...Job:Regulatory Affairs Specialist/Senior Specialist/Assistant Manager
Experience:1012 Years
Skills:
The ideal candidate would... ...knowledge of MSEXCEL and PowerPoint will be preferred.
• Association or working experience in Central/State regulatory authority will...
...Manager – Global Regulatory Affairs Location – Head-Office, Bangalore, IN
BIOCON BIOLOGICS
Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition...
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...
...development, manufacturing, clinical development, regulatory approvals to commercialization in... ...emerging markets. Global Regulatory Affairs
The Global Regulatory Affairs (GRA) at... ...–Hiring, Training and mentoring associates, leave management, appraisals, KRAs....