GRA - Chemistry, Manufacturing, and Control (CMC) is responsible for
regulatory strategy, submissions and regulator interactions associated
with all products in development up to and including initial market
applications in all countries around the globe. GRA-CMC is also
responsible for the regulatory strategy and post approval submissions
for Commercial Products to ensure reliable supply and continuous
improvements. This includes small molecules, biotechnology, Insulin
products, devices, and drug / device combination products.
They work in collaboration with other areas of GRA, Product Research &
Development, Technical Services / Manufacturing Sciences, Quality,
Product Delivery PM, PPM, and PDS to develop CMC regulatory
strategies, provide regulatory risk assessments, and implement
regulatory processes to support products and CMC teams.
Vision
To be Industry Leading in Application of CMC Regulatory Science,
Leveraging Quality by Design to Obtain Timely Approvals that Enable
Continuous Improvements in Product Quality and Manufacturing
Processes.
The role
My client is looking for an associate to lead and partner with
Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in
the various aspects of global marketing authorization submission
management processes. This exciting opportunity will enable you to
utilize your project management and communication skills to advance
the submission process for new molecules.
_YOU WILL_ also partner with GRA-CMC Scientists to help build and
manage submission content, provide guidance on structure and content
placement within Common Technical Document (CTD) registration
submissions, and to provide assistance with submission related
Ministry of Health responses or our client?s affiliate questions.
_YOU WILL_ work within regulations to expedite the registration and
lifecycle maintenance of products. This is accomplished by a strong
working understanding of internal procedures, guidances and regulatory
precedence.
_YOU WILL_ triage and lead the communications between our client?s
Affiliates, GRA-CMC Scientists, and Specialists.
_YOU WILL_ be the point person for communication regarding submission
tracking requirements to both GRA-CMC Scientists and internal
customers.
Regulatory & Drug Development Expertise ?
* Lead CMC submission management process by providing knowledge of CMC
regulatory requirements, including a comprehensive knowledge of ICH
CTD and evolving global agency standards, of CMC RA submission
processes, electronic submission regulations and guidance regarding
structure requirements to CMC development teams regarding global CTAs
and registration dossiers. ?
* Responsible for preparing CMC CTD content consistent with approved
manufacturing changes, technical reports and procedural requirements.
?
* Partner with the CMC RA Scientist to plan and prepare submission
content to support clinical studies and manufacturing process changes
for development and marketed products. ?
* Partner with the CMC RA Scientist to drive the execution of
submission planning for global registration and maintenance
submissions. ?
* Responsible for triage of our client?s affiliate inquires and
requests and when necessary consults with CMC RA Scientist for
guidance in effort to prepare responses to questions. ?
* Implement and in some cases interpret global regulations and
guidances and look to regulatory precedence into submission processes
and publishing standards to ensure final document content and
structure are aligned with local regulatory requirements. Partner with
our client affiliate regulatory staff, as necessary, to gain alignment
on establishing new submission standards to meet local agency
requirements.
Lead, Influence, Partner ?
* Create an environment within the Global Regulatory Area and across
CMC development teams that encourages open discussions on issues to
achieve a robust outcome on project decisions. Constructively
challenge teams to reach the best solutions to issues. ?
* Leverage internal forums to continue to develop and share regulatory
and drug development expertise to meet critical product registration
timelines and electronic submission structure and content
requirements. ?
* Communicate effectively to guide and influence within work
group/function and with development team regarding life-cycle
management processes ?
* Demonstrate strong problem-solving skills and ability to address and
effectively communicate regulatory issues across multiple functions
and geographies
Basic
_QUALIFICATIONS_ ?
* Bachelor?s Degree in a scientific or health sciences discipline
(e.g. pharmacy, chemistry or related scientific discipline)
Knowledge of pharmaceutical drug development or industry-related
experience preferred CMC Department
GRA - Chemistry, Manufacturing, and Control (CMC) is responsible for
regulatory strategy, submissions and regulator interactions associated
with all products in development up to and including initial market
applications in all countries around the globe. GRA-CMC is also
responsible for the regulatory strategy and post approval submissions
for Commercial Products to ensure reliable supply and continuous
improvements. This includes small molecules, biotechnology, Insulin
products, devices, and drug / device combination products.
They work in collaboration with other areas of GRA, Product Research &
Development, Technical Services / Manufacturing Sciences, Quality,
Product Delivery PM, PPM, and PDS to develop CMC regulatory
strategies, provide regulatory risk assessments, and implement
regulatory processes to support products and CMC teams.
Vision
To be Industry Leading in Application of CMC Regulatory Science,
Leveraging Quality by Design to Obtain Timely Approvals that Enable
Continuous Improvements in Product Quality and Manufacturing
Processes.
The role
My client is looking for an associate to lead and partner with
Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in
the various aspects of global marketing authorization submission
management processes. This exciting opportunity will enable you to
utilize your project management and communication skills to advance
the submission process for new molecules.
_YOU WILL_ also partner with GRA-CMC Scientists to help build and
manage submission content, provide guidance on structure and content
placement within Common Technical Document (CTD) registration
submissions, and to provide assistance with submission related
Ministry of Health responses or our client?s affiliate questions.
_YOU WILL_ work within regulations to expedite the registration and
lifecycle maintenance of products. This is accomplished by a strong
working understanding of internal procedures, guidances and regulatory
precedence.
_YOU WILL_ triage and lead the communications between our client?s
Affiliates, GRA-CMC Scientists, and Specialists.
_YOU WILL_ be the point person for communication regarding submission
tracking requirements to both GRA-CMC Scientists and internal
customers.
Regulatory & Drug Development Expertise ?
* Lead CMC submission management process by providing knowledge of CMC
regulatory requirements, including a comprehensive knowledge of ICH
CTD and evolving global agency standards, of CMC RA submission
processes, electronic submission regulations and guidance regarding
structure requirements to CMC development teams regarding global CTAs
and registration dossiers. ?
* Responsible for preparing CMC CTD content consistent with approved
manufacturing changes, technical reports and procedural requirements.
?
* Partner with the CMC RA Scientist to plan and prepare submission
content to support clinical studies and manufacturing process changes
for development and marketed products. ?
* Partner with the CMC RA Scientist to drive the execution of
submission planning for global registration and maintenance
submissions. ?
* Responsible for triage of our client?s affiliate inquires and
requests and when necessary consults with CMC RA Scientist for
guidance in effort to prepare responses to questions. ?
* Implement and in some cases interpret global regulations and
guidances and look to regulatory precedence into submission processes
and publishing standards to ensure final document content and
structure are aligned with local regulatory requirements. Partner with
our client affiliate regulatory staff, as necessary, to gain alignment
on establishing new submission standards to meet local agency
requirements.
Lead, Influence, Partner ?
* Create an environment within the Global Regulatory Area and across
CMC development teams that encourages open discussions on issues to
achieve a robust outcome on project decisions. Constructively
challenge teams to reach the best solutions to issues. ?
* Leverage internal forums to continue to develop and share regulatory
and drug development expertise to meet critical product registration
timelines and electronic submission structure and content
requirements. ?
* Communicate effectively to guide and influence within work
group/function and with development team regarding life-cycle
management processes ?
* Demonstrate strong problem-solving skills and ability to address and
effectively communicate regulatory issues across multiple functions
and geographies
Basic
_QUALIFICATIONS_ ?
* Bachelor?s Degree in a scientific or health sciences discipline
(e.g. pharmacy, chemistry or related scientific discipline)
Knowledge of pharmaceutical drug development or industry-related
experience preferred
We need : English (Good)
Type: Permanent
Payment:
Category: Others
