the recruitment, retention and resource assignment of the regulatory
associates managing submissions in the Global Regulatory Affairs (GRA)
organization. The RDE Manager provides leadership, direction, as well
as technical / process expertise to the regulatory associates
responsible for the regulatory submission management process across
the CTD modules. This position provides strategic input, focuses on
results, thinks critically, and emphasizes and drives regulatory team
collaboration to the achievement of goals and objectives.
The RDE Manager leads the regulatory associates responsible for the
execution and delivery of submissions to global health authorities.
The RDE Manager supports execution of the submission plans that are
aligned with the molecule team. To achieve this goal, the RDE Manager
uses their regulatory and submission expertise, a strong working
knowledge of customers, internal procedures, guidances and regulatory
precedence.
Primary
RESPONSIBILITIES:
This job description is intended to provide a general overview of the
job requirements at the time it was prepared. The job requirements of
any position may change over time and may include additional
responsibilities not specifically described in the job description.
Consult with your supervision regarding your actual job
responsibilities and any related duties that may be required for the
position.
People Management ?
* Recruit, develop, and retain a diverse and highly capable workforce
?
* Ensure robust individual training plans and timely completion of
required training for direct reports. ?
* Support and enable talent identification and career development that
reflects an end-to-end mindset and demonstrates judgement-based
decision making ?
* Ensure regulatory publisher competencies are present and
continuously improving ?
* Manage workload based on portfolio prioritization, regional
requirements, and individual level of expertise, and address
implications to overall resource management and strategies. ?
* Support and encourage a culture of innovation and model inclusivity
to ensure diverse voices and ideas are heard and considered
Regulatory Delivery ?
* Demonstrate strong business acumen, problem-solving skills, and
learning agility to help teams plan for contingencies, and adjust to
change ?
* Manage global cross-functional communication and issue escalations
to ensure alignment on delivery and execution. ?
* Understand regulations and how they apply to the submission process
and use this to provide technical leadership to the team ?
* Utilize regulatory and process knowledge to drive decision-making ?
* Ensure strategies for enhancing focus on the customer exist and are
implemented. ?
* Actively partner with upstream work units to ensure process
alignment and best practices. ?
* Develop, implement, and monitor metrics to ensure continuous
improvement and compliance. ?
* Partner with quality in both process improvements and deviation
management. ?
* Monitor regulation/external environment as appropriate
Effective Management ?
* Align resources based on portfolio prioritization while
demonstrating flexibility across business units and geographies ?
* Ensure a compliance culture and state of inspection readiness ?
* Model judgement-based decision making to navigate compliance and
quality requirements ?
* Responsible for continuous improvement and shared learning and
collaborates with process owners in the spirit of streamlining,
efficiency, and effectiveness of submission management ?
* Provide resources for area strategic initiatives and process
improvements. ?
* Proactively seeks feedback on team?s performance for continuous
learning
Minimum Qualification
REQUIREMENTS:
* Bachelors Degree, preferably in a scientific or health-related field
?
* Fluent in English, verbal and written ?
* Previous experience in the pharmaceutical industry ?
* Must understand regulatory processes and the interdependencies of
various tasks that require coordination among cross-functional team
members and possibly third parties ?
* Strong self-management and organizational skills; able to manage
workload, set personal and team priorities and adjust as needed ?
* Strong problem-solving skills; able to anticipate and recognize
systemic problems, diagnose root causes and take corrective actions to
prevent reoccurrence ?
* Strong communication skills; able to communicate clearly and
succinctly with team members and leadership ?
* Ability to embrace the diversity of thought to model innovative
behaviors (e.g., reaching across boundaries, inspire and empower
others and lead decisively in the midst of ambiguity)
Other Information/Additional Preferences:
Prior experience in working with external business partners (e.g.,
CRO, Alliance, Joint Venture), Conflict management/conflict resolution
skills,
_ABLE TO_ influence others without direct authority, Travel may be
required The Regulatory Delivery Excellence (RDE) Manager is responsible for
the recruitment, retention and resource assignment of the regulatory
associates managing submissions in the Global Regulatory Affairs (GRA)
organization. The RDE Manager provides leadership, direction, as well
as technical / process expertise to the regulatory associates
responsible for the regulatory submission management process across
the CTD modules. This position provides strategic input, focuses on
results, thinks critically, and emphasizes and drives regulatory team
collaboration to the achievement of goals and objectives.
The RDE Manager leads the regulatory associates responsible for the
execution and delivery of submissions to global health authorities.
The RDE Manager supports execution of the submission plans that are
aligned with the molecule team. To achieve this goal, the RDE Manager
uses their regulatory and submission expertise, a strong working
knowledge of customers, internal procedures, guidances and regulatory
precedence.
Primary
RESPONSIBILITIES:
This job description is intended to provide a general overview of the
job requirements at the time it was prepared. The job requirements of
any position may change over time and may include additional
responsibilities not specifically described in the job description.
Consult with your supervision regarding your actual job
responsibilities and any related duties that may be required for the
position.
People Management ?
* Recruit, develop, and retain a diverse and highly capable workforce
?
* Ensure robust individual training plans and timely completion of
required training for direct reports. ?
* Support and enable talent identification and career development that
reflects an end-to-end mindset and demonstrates judgement-based
decision making ?
* Ensure regulatory publisher competencies are present and
continuously improving ?
* Manage workload based on portfolio prioritization, regional
requirements, and individual level of expertise, and address
implications to overall resource management and strategies. ?
* Support and encourage a culture of innovation and model inclusivity
to ensure diverse voices and ideas are heard and considered
Regulatory Delivery ?
* Demonstrate strong business acumen, problem-solving skills, and
learning agility to help teams plan for contingencies, and adjust to
change ?
* Manage global cross-functional communication and issue escalations
to ensure alignment on delivery and execution. ?
* Understand regulations and how they apply to the submission process
and use this to provide technical leadership to the team ?
* Utilize regulatory and process knowledge to drive decision-making ?
* Ensure strategies for enhancing focus on the customer exist and are
implemented. ?
* Actively partner with upstream work units to ensure process
alignment and best practices. ?
* Develop, implement, and monitor metrics to ensure continuous
improvement and compliance. ?
* Partner with quality in both process improvements and deviation
management. ?
* Monitor regulation/external environment as appropriate
Effective Management ?
* Align resources based on portfolio prioritization while
demonstrating flexibility across business units and geographies ?
* Ensure a compliance culture and state of inspection readiness ?
* Model judgement-based decision making to navigate compliance and
quality requirements ?
* Responsible for continuous improvement and shared learning and
collaborates with process owners in the spirit of streamlining,
efficiency, and effectiveness of submission management ?
* Provide resources for area strategic initiatives and process
improvements. ?
* Proactively seeks feedback on team?s performance for continuous
learning
Minimum Qualification
REQUIREMENTS:
* Bachelors Degree, preferably in a scientific or health-related field
?
* Fluent in English, verbal and written ?
* Previous experience in the pharmaceutical industry ?
* Must understand regulatory processes and the interdependencies of
various tasks that require coordination among cross-functional team
members and possibly third parties ?
* Strong self-management and organizational skills; able to manage
workload, set personal and team priorities and adjust as needed ?
* Strong problem-solving skills; able to anticipate and recognize
systemic problems, diagnose root causes and take corrective actions to
prevent reoccurrence ?
* Strong communication skills; able to communicate clearly and
succinctly with team members and leadership ?
* Ability to embrace the diversity of thought to model innovative
behaviors (e.g., reaching across boundaries, inspire and empower
others and lead decisively in the midst of ambiguity)
Other Information/Additional Preferences:
Prior experience in working with external business partners (e.g.,
CRO, Alliance, Joint Venture), Conflict management/conflict resolution
skills,
_ABLE TO_ influence others without direct authority, Travel may be
required
We need : English (Good)
Type: Permanent
Payment:
Category: Others
