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About Us
We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with ...
...effective review.
Responsible for authoring quality and timely CMC contributions for license maintenance activities such as US... ...and general instruction on the process and desired outcome.
Accountable for ensuring compliance to the submission standards, procedures...
...always looking for curious minds that see themselves imagining the unimageable with us.
Your Role:
Accountability:
This Role will be fully dedicated on CMC regulatory intelligence team activities, aiming to enhance the GRA CMC knowledge sharing culture, with a...
...Job Description
Job Title: International CMC RA Manager I
Career Level - D
Introduction to Role:
Join us at AstraZeneca... ...move with agility in our Biopharmaceuticals R&D department.
Accountabilities :
You will be responsible for managing the timely...
...career to new heights.
Making animals’ lives better makes life better – join our team today!
The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission...
...increased revenue growth and profitability.
Participate in Key Account and relationship management as needed.
Work with peers to... ...Abilities
Knowledge of Pharma R&D outsourcing market in General and CMC / CDMO Services is a must
A hands-on attitude with an...
...Job Description: Position : Assistant Scientist / Scientist - CMC (Formulation)
Reporting to : Lead scientist/Associate Director -CMC
Location : Hyderabad, India
Education/Qualifications : M. Pharm/Ph.D from premier institute.
Experience : At least 7-9 years...
Primarily Responsible for managing assigned regulatory projects/ CMC programs of moderate complexities, managing and ensuring daily delivery of regulatory and strategic activities, post- approval regulatory submission activities for Brands in collaboration with Global Regulatory...
...Associate Manager, Regulatory Affairs (CMC)
at ClinChoice (View all jobs)
Bangalore or Hyderabad - India
ClinChoice is a global... ...and foresee any risks that are likely to arise.
Is accountable to ensure that team performs with compliance to accepted quality...
JOB RESPONSIBILITIES
Functions as product owner for site transfer submissions for assigned products, working with cross functional team, site team and corporate regulatory team to ensure preparation of quality global regulatory strategy document and supplements / variations...
...more: careers.bms.com/working-with-us.
Position Summary
The CMC Regulatory Associate Director, Small Molecule is responsible for... ..., while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each...
...Analytical development for formulations
Working experience with complex injectables, hydrogels, large molecules, peptides etc. preferred
Sound scientific skills
Good communication skills
Engagement & accountability towards the defined purpose
Good team player...
$ 55000 p.a.
...and business need.
The Role
We are seeking an independent and scientifically driven Senior Manager/Associate Director of Regulatory CMC who will be responsible for overseeing the development and implementation of global CMC regulatory strategies related to the clinical...
Work closely with Cloud product owners to understand, analyze product requirements and provide feedback.
Organized and goal-focused, ability to deliver in a fast-paced environment.
Architecture design and review of Cloud data pipeline, including data ingestion, extraction...
...Site Name: Bengaluru Luxor North Tower
Posted Date: Mar 21 2024
Job Purpose :
Manages the CMC regulatory activities of multiple projects and dosage forms and represent the Regulatory group across business and organizational boundaries.
Key Responsibilities :...
...Job Description: Position: Assistant Scientist / Scientist - CMC (Formulation) - Injectables
Reporting to: Lead scientist/Associate Director -CMC
Location: Hyderabad, India
Education/Qualifications: M. Pharm/Ph.D from premier institute.
Experience: At least...
...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 lifecycle...
Job Responsibilities :
Functions as the Global Product Owner (GPO) or supports a GPO for Life Cycle Management (LCM), working with Cross-Functional Teams (CFT) to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries.
Responsible for the ...
The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to...
...Author high quality global CMC documentation for Health Authority submission throughout
the product lifecycle, applying agreed CMC... ...and lead (a cross-functional team) in a matrix environment.
Accountability, Collaborating across boundaries.
Cross Cultural Experience...