...Position purpose
For assigned products: Regulatory Acceleration process Plan to gain rapid... ...ensure a high standard of regulatory compliances, SEC/TC/APEX Preparation, in order to achieve... ..., Sales, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams...
...Job Description
Job Title: Regulatory Affairs Manager I
Career Level - D
Introduction to role:
Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management...
...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...
$ 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... ...coordination with partner companies and vendors.
â¢Ensure compliance of all Alpine activities with applicable global regulations,...
...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...
...expertise and talent to develop the next generation of life-changing therapeutics.
The Regulatory Compliance Specialist for Cytiva is responsible is part of the Quality and Regulatory Affairs team located in Bangalore and will be Hybrid in nature. At Cytiva, our vision is, to...
Rs 10000 - Rs 25000 per month
...We are hiring for Regulatory Affairs Executive. Qualification: B.pharm/M.pharm
Age criteria: below 30
Experience - 0 to 2 years only
Location - Sola, Ahmedabad
Work mode - on site
:
Should have worked in Regulated Market (ROW).
Dossier Submission, Dossier...
...Regulatory Affairs Specialist - CMC Variations/Submissions
12 month contract - Immediate start
Overview: Join our Regulatory Affairs... ...Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.
Key...
...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...
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... ...of EU regulatory framework and guidelines
Experience in compliance and maintaining product life cycle databases and RIMs systems...
JOB DESCRIPTION
Job Title
Regulatory Affairs Manager
Job Description
Job Description
Business Title: Manager - Regulatory... ...required to ensure first time right in submissions.
Manage compliance to relevant regulations and other Regulatory Requirements and...
...Executive - Regulatory Affairs (PLMDS)
at ClinChoice (View all jobs)
Chennai - India
Are you interested in working directly for a single... ...required on-the-job training courses to ensure training compliance is preserved.
Continuous improvement of selected processes...
...for clean electricity. Come be a part of our success story!
Regulatory Affairs – (Executive) (m / f / d)
Full-time employee, Gurugram... ...functions including but not limited to:
Statutory clearances & compliance.
Strategic planning & management - Liaison & Coordination....
...combination of this will lead to a truly differentiated experience for you.
If this excites you, then apply below.
Lead Regulatory Affairs
You will be responsible for :
Responsible for Regulatory intelligence dissemination and coordination, this includes
-...
Responsibilities
Prepare applications for the permits, licenses, certificates, authorizations, and other approvals that the organization needs to conduct its business activities; and produce, sell, and distribute its goods and services. These may include product licenses...
...Job Title: Head of Compliance and Legal Affairs
Location: Noida
Salary: 40L-60L per annum
Experience: 15-15 years
Job Description:... ...standards applicable to the company's operations.
Monitor regulatory developments and assess their impact on the organization....
...Lead consultant, Regulatory Affairs Pharmaceutical - LIF016391
Genpact (NYSE: G) is a global professional services and solutions firm delivering... ...deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors...
...Associate Manager, Regulatory Affairs (CMC)
at ClinChoice (View all jobs)
Bangalore or Hyderabad - India
ClinChoice is a global full... ...assessment, and execution of initiated/assigned change controls.
Compliance to regulatory work processes, policies, and procedures....
Rs 5 - 6 lakhs p.a.
...complex activities, often with competing priorities.
Most regulatory affairs positions are full time.
Regulatory Responsibility means... ...of preparation of dossier, ECTD & ACTD etc.
Regulatory compliance is when a business follows state, federal, and international...
...Position Overview:
~ Handling assigned activities in the regulatory department.
Experience:
~5-8 years
Qualification... ...latest guidances assuring technical congruency and regulatory compliance.
Identify the required documentation for EU regulatory submissions...
...services. We are looking for an experienced individual in GDD Regulatory Affairs to lead the business analysis activities for the solutions... ...• Must have proven strong knowledge of SDLC, Validation & Compliance
• Should be self-motivated, take complete ownership for the...
Dear Candidates, Greetings from Randstad India ! We have an opening for the role of Assistant Manager - Regulatory Affairs with a leading pharma company in India. Interested candidates can drop your resume to the mail id ****@*****.*** The details are below...
...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...
...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...
Job Description
JOB DESCRIPTION
Regulatory Affairs 3-4 years Experience Medical Devices & Drug productsSummary:
Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical...
...Lead consultant, Regulatory Affairs Pharmaceutical - LIF016236
With a startup spirit and 115,000 + curious and courageous minds, we have the... ...deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors...
...equity fund administration; advisory firm set-up, regulatory registration and infrastructure design; ongoing regulatory compliance (SEC, CFTC, and 40 Act); financial controls... ...Associate: Enterprise Risk and Regulatory Affairs will provide support:
to the attainment of...
...Essential
• Ph.D. in relevant discipline from reputed institution.
• First Class B.Pharm with Masters degree in Pharmaceutical Regulatory Affairs / Pharmaceutics.
• Registration as a pharmacist under the Pharmacy Act, 1948, as amended from time to time, including any...
...globally.
Role and Responsibilities:
We are seeking a Manager Regulatory Affairs to join our team. In this role you will be responsible for... ...with internal personnel and external agencies to ensure compliance with relevant regulatory requirements. Additionally you will...