My client is looking to fill a Regulatory Affairs Manager role within
their company, this main objectives of the role;
Main Objective of Role:
RA Submissions Management
* Manage and oversee the coordination of regulatory submissions
assigned to RA Submissions Team.
* Ensure that the documentation compiled by team is complete and
complies with applicable regulatory requirements.
* Tracking submission progress through efficient communication to
relevant entities/stakeholders and local service providers.
* Close cooperation and communication with other
entities/departments in order to obtain timely product approvals.
* Ensure that information exchange and weekly and monthly reporting
is followed by the RA Submissions Team.
* Ensure that timely responses to regulatory agencies queries raised
during the evaluation process are submitted by the team.
* Inform relevant entities/departments of developments in national
and EU regulation/legislation.
* Develop and maintain regulatory knowledge within the department.
* Ensure Marketing Authorisation Applications (MAAs) are current and
compliant through an established and experienced Regulatory Affairs
Team.
* Provide support to management in respect of registration strategy.
* Ensure that Change Control requests are assessed and regulatory
impact assessment is performed with respect to regulatory
requirements.
* Assist in due diligence process for new business development
through audit/review of dossier.
* Lead cross functional meetings and processes with regard to
implementation of regulatory requirements, in order to obtain timely
regulatory approvals.
* Ensure all activities are within the framework of the
company&#**Apply on the website**;s Quality Management System,
including the setting and achievement of relevant KPIs.
* Responsible for the achievement of department/division/unit
productivity and quality goals.
Department Management
* Manage a team of Regulatory Affairs Officers with varying levels of
experience
* Create ways of doing things differently and more effectively
within the department
* Challenge current ways of working with a view to suggesting more
effective and efficient processes.
* Maintain staff by recruiting, selecting and training employees
* Accomplish staff results by communicating job expectations;
planning, monitoring, and appraising job results; coaching,
counselling, and disciplining employees; developing, coordinating, and
enforcing systems, policies, procedures, and productivity standards
* Control of department finances including budget development
* Build expertise and deep knowledge within the Regulatory Affairs
Team
* Adhere to Company Health & Safety procedures
* Participate in training programmes
* Any other duties as assigned by Senior Management
Skills:
* Results and performance driven deliver results that meet or exceed
expectations
* Sense of urgency responding to issues and opportunities in a
timely manner
* Take ownership and accountability for activities
* Intellectual curiosity willing to suggest and try new ideas
* Accuracy and Attention to detail
* Positive and pro-active approach to business tasks
* Hands on Proactive People Management
* Excellent interpersonal and communications skills.
* A solutions provider with strong multi-tasking abilities
* Ability to lead and support several concurrent projects/products
and develop strong relationship within cross-functional teams.
* Positive can do attitude
Attributes:
* Highly driven with enthusiasm to meet role requirements and to cope
under demanding pressure
* Ability to prioritise decisions and activities to ensure efficient
use of resources and address critical issues impacting the business
* Ability to influence and partner with cross-site teams in a global
pharmaceutical organisation
* Execution persistent drive for results utilising sound project
focus, organisational and problem solving skills.
* Enthusiasm and Drive to take complete ownership and drive process
improvement initiatives.
* Be able to work autonomously and have good problem solving skills.
* Occasional travel is part of the job
Qualifications:
* A minimum of relevant Life Science degree and/or a minimum of 5
years Submissions experience preferably with management/supervisory
experience.
* Strong working knowledge of regulatory requirements and procedures
required, with a solid understanding of EU regulations. This includes
good understanding of eCTD requirements.
* Solid knowledge of IT tools specific for in RA and pharmaceutical
sector (as eCTD, databases, change control management etc.) required.
JOB DESCRIPTION
My client is looking to fill a Regulatory Affairs Manager role within
their company, this main objectives of the role;
Main Objective of Role:
RA Submissions Management
* Manage and oversee the coordination of regulatory submissions
assigned to RA Submissions Team.
* Ensure that the documentation compiled by team is complete and
complies with applicable regulatory requirements.
* Tracking submission progress through efficient communication to
relevant entities/stakeholders and local service providers.
* Close cooperation and communication with other
entities/departments in order to obtain timely product approvals.
* Ensure that information exchange and weekly and monthly reporting
is followed by the RA Submissions Team.
* Ensure that timely responses to regulatory agencies queries raised
during the evaluation process are submitted by the team.
* Inform relevant entities/departments of developments in national
and EU regulation/legislation.
* Develop and maintain regulatory knowledge within the department.
* Ensure Marketing Authorisation Applications (MAAs) are current and
compliant through an established and experienced Regulatory Affairs
Team.
* Provide support to management in respect of registration strategy.
* Ensure that Change Control requests are assessed and regulatory
impact assessment is performed with respect to regulatory
requirements.
* Assist in due diligence process for new business development
through audit/review of dossier.
* Lead cross functional meetings and processes with regard to
implementation of regulatory requirements, in order to obtain timely
regulatory approvals.
* Ensure all activities are within the framework of the
company&#**Apply on the website**;s Quality Management System,
including the setting and achievement of relevant KPIs.
* Responsible for the achievement of department/division/unit
productivity and quality goals.
Department Management
* Manage a team of Regulatory Affairs Officers with varying levels of
experience
* Create ways of doing things differently and more effectively
within the department
* Challenge current ways of working with a view to suggesting more
effective and efficient processes.
* Maintain staff by recruiting, selecting and training employees
* Accomplish staff results by communicating job expectations;
planning, monitoring, and appraising job results; coaching,
counselling, and disciplining employees; developing, coordinating, and
enforcing systems, policies, procedures, and productivity standards
* Control of department finances including budget development
* Build expertise and deep knowledge within the Regulatory Affairs
Team
* Adhere to Company Health & Safety procedures
* Participate in training programmes
* Any other duties as assigned by Senior Management
Skills:
* Results and performance driven deliver results that meet or exceed
expectations
* Sense of urgency responding to issues and opportunities in a
timely manner
* Take ownership and accountability for activities
* Intellectual curiosity willing to suggest and try new ideas
* Accuracy and Attention to detail
* Positive and pro-active approach to business tasks
* Hands on Proactive People Management
* Excellent interpersonal and communications skills.
* A solutions provider with strong multi-tasking abilities
* Ability to lead and support several concurrent projects/products
and develop strong relationship within cross-functional teams.
* Positive can do attitude
Attributes:
* Highly driven with enthusiasm to meet role requirements and to cope
under demanding pressure
* Ability to prioritise decisions and activities to ensure efficient
use of resources and address critical issues impacting the business
* Ability to influence and partner with cross-site teams in a global
pharmaceutical organisation
* Execution persistent drive for results utilising sound project
focus, organisational and problem solving skills.
* Enthusiasm and Drive to take complete ownership and drive process
improvement initiatives.
* Be able to work autonomously and have good problem solving skills.
* Occasional travel is part of the job
Qualifications:
* A minimum of relevant Life Science degree and/or a minimum of 5
years Submissions experience preferably with management/supervisory
experience.
* Strong working knowledge of regulatory requirements and procedures
required, with a solid understanding of EU regulations. This includes
good understanding of eCTD requirements.
* Solid knowledge of IT tools specific for in RA and pharmaceutical
sector (as eCTD, databases, change control management etc.) required.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
