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...expertise by leading teams in the delivery of high-quality clinical regulatory documents. They work primarily at the document development level... ...to achieve successful submissions and approvals.
The Manager II, Clinical Regulatory Writing is expected to:
With limited...
...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...
...Functional Job Title: Officer/ Manager
Reports to: AVP for Regulatory Reporting
Department/ Division: Report Preparation (Liquidity & Branch Reporting Team)
Basic Purpose of Job:
This role will be responsible for supporting the Liquidity (viz. Liquidity Coverage...
...local Regulators including but not limited to APRA, HKMA,MAS and several other national competent authorities on various regulatory reports, internal management and external ad-hoc reporting. The individual will have specific reporting duties within the team, provide guidance...
...Making animals’ lives better makes life better – join our team today!
Position Description:
The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission preparation...
...The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller’s Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting...
...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...
...Are you passionate about ensuring compliance and streamlining regulatory processes in the dynamic field of life sciences? Do you have a... ...regarding local SOP updates as necessary, while also creating and managing Change Requests and deviations.
Qualifications
To be...
...opportunity waiting for
you as “CMC Regulatory
Professional II” with us.... ...and life
cycle management of our
products. We are...
...comprised of +60 experienced professionals associated with key regulatory processes covering CMC, Medical Device Reporting (MDR) and submission... ...of regulatory files, product registrations and life cycle management of our products. We are responsible for driving the RA CMC...
...Department:
Regulatory Affairs CMC & Device
Are you passionate about what you are doing? Do you want to build excellence within processes... ...of regulatory files, product registrations and life cycle management of our products. We are responsible for driving the RA CMC strategies...
...the products in the product portfolio in collaboration with other stakeholders
Compiling variation packages
Experienced in managing, regulatory database and Trackwise.
Your experience and qualifications
Qualification:
Academic degree- and thinking level with a...
...develop the next generation of life-changing therapeutics.
The Regulatory Compliance Specialist for Cytiva is responsible is part of the... ...to changes to regulations.
Participate/support Project Management Office (PMO) projects
The essential requirements...
...Regulatory Affairs Specialist
Responsibilities:
Prepare and submit regulatory documentation for new and existing medical products, including... ...with regulatory agencies and respond to their inquiries.
Manage the regulatory approval process from pre-clinical development to...
...Medical Device Regulatory Affairs Job duties of a Regulatory Affairs Specialist include:
Developing and implementing regulatory strategies... ...and support to other departments on regulatory matters
Managing regulatory audits and inspections.
Interested to apply can...
...Planning
Are you detail-oriented and passionate about ensuring regulatory compliance? Do you thrive in a fast-paced and global... ...coordinate packaging material for global markets.
Labelling Request Management: Assess and align expectations for new or updated packaging materials...
...The position
As Associate Regulatory Professional II, you will play a crucial role in driving, coordinating, and actively following up... ...teams across the organization and all countries in Europe.
Managing initial clinical trial application submissions in the EU according...
...the preparation of submission content and use of GSK document management systems and procedures
Works across the functions and can work... ..., to expedite submission, review and approval of global regulatory applications
Job-Related Experience
~2-5 years of experience...
...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...
Rs 7 - 11 lakhs p.a.
...process and application requirements. Must have Skills : SAP EHS Regulatory Compliance Good to Have Skills : No Technology Specialization... ...should be able to design, implement and test SAP Environmental Management and Risk Assessment Modules b Perform data migration and configure...