Fantastic opportunity for an experienced Regulatory Affairs Manager to
join the Senior Leadership team of a leading manufacturer and marketer
of healthcare products here in Ireland. The Irish sites are part of a
large global pharmaceutical and biotechnology company and are based in
here in the South East.
Reporting to the Managing Director, the role holder will be a member
of the SLT. The Head of Regulatory Affairs will: ?
* Ensure the provision of all operational and advisory activities
relating to regulatory submissions worldwide, timely approvals of
product licences and subsequent licence maintenance in a
cost-effective manner; ?
* Allocate and prioritise tasks within the department to meet business
needs; ?
* Identify and address the training needs of the department; ?
* Represent the Regulatory Affairs department at Senior Leadership
Team meetings.
?_KEY RESPONSIBILITIES_ (include but not limited to): ?
* As a senior departmental member, actively contribute to the routine
operational use of, and input to, the site Pharmaceutical Quality
System by providing functional guidance and support, ensuring the
system is used according to defined procedure. ?
* Plan and execute regulatory strategies for new products to ensure
the fastest possible introduction of those products to the market,
ensure that new product development programmes are progressed with due
regard to regulatory requirements and ensure that all information
provided in submissions is of a high standard, complies with
regulatory requirements and is presented in a professional manner. ?
* Support the regulatory compliance of the company with the conditions
of its product licences and manufacturing licences. ?
* Recruit, manage and develop staff of the calibre required to meet
the present and future needs of the company. ?
* Provide an information and advisory service on regulatory affairs to
ensure all relevant personnel within the company are briefed on
current and future regulatory legislation and requirements. ?
* Represent the Regulatory Affairs Department at Senior Leadership
Team meetings. ?
* Main activities are planning; management of staff and their work;
some participation in that work; deciding on regulatory strategy and
advice to management on regulatory matters. ?
* Represent the Regulatory Department at internal and external
meetings. ?
* Propose and develop regulatory strategies for new products. ?
* Assess and advise on the quality of dossiers offered for sale by
other companies. ?
* Identify and address the training needs of the department. ?
* Allocate and prioritise work within the department to ensure the
company needs are met. ?
* Review personally or by delegation GMP documentation, including
change controls, for regulatory compliance and evaluate the regulatory
impact. ?
* Ensure departmental SOPs are maintained and complied with. ?
* Final sign-off of artwork. ?
* Monitor legislation and professional publications to maintain
awareness of current regulatory practice and advise departments on
regulatory requirements/strategy. ?
* Support to, and operational use of, the Pharmaceutical Quality
System will be achieved by monitoring and maintaining the integrity of
the Pharmaceutical Quality Systems, through implementation of
improvements and ensuring all direct reports engage with and utilise
the system in accordance with defined procedures. ?
* The job holder will participate in the provision of all metric data,
and associated required information essential for the Quality
Management Review relating to their functional area and contribute to
improving the effectiveness of the system by reporting on its
performance. In addition, they will actively participate in and
promote continuous improvements to products, processes and the
Pharmaceutical Quality System, through identification and delivery of
such enhancements, with the aim of minimising patient, customer and
business risks.
* Preparation of annual department budget
Key
_REQUIREMENTS_ include:
Educated to at least honours degree level in a life science with at
least **Apply on the website** years? experience in regulatory
affairs in an international role.
Membership of The Organisation for Professionals in Regulatory Affairs
(TOPRA) is essential.
Have an appreciation of all aspects of the working of the
pharmaceutical industry.
_ABILITY TO_ motivate and manage subordinates and colleagues.
Requires the ability to present the Company?s interests in a
professional and authoritative manner and to conduct negotiations with
regulatory bodies at the highest level.
Sees the big picture, understands key business drivers, anticipates
challenges, navigates ambiguity and complexity; keeps people focused
on the right goals.
Outstanding organisational and time-management skills.
Uses good judgement and is able to make effective decision on complex
issues despite short time lines and pressure.
Exceptional ability to leverage/collaborate effectively with internal
and external stakeholders.
Excellent written and verbal communication and interpersonal skills.
Secures resources and builds the team, system and culture needed to
meet commitments and drive results, balances short and long terms
needs and goals, and effectively leads change.
Independent, critical thinker with strong decision-making skills.
Comfortable working in a busy, fast paced regulated manufacturing
environment.
By applying to RPG Recruitment, you are consenting for your details to
be reviewed by RPG Recruitment and held on our database. If at any
stage in the future, you would like to remove your details from our
database , you can do so by requesting in writing for your details to
be removed in line with our privacy policy. RPG Recruitment operate to
the highest ethical standards of recruitment at all times Position: ?Head of Regulatory Affairs ?(SLT Level)
Fantastic opportunity for an experienced Regulatory Affairs Manager to
join the Senior Leadership team of a leading manufacturer and marketer
of healthcare products here in Ireland. The Irish sites are part of a
large global pharmaceutical and biotechnology company and are based in
here in the South East.
Reporting to the Managing Director, the role holder will be a member
of the SLT. The Head of Regulatory Affairs will: ?
* Ensure the provision of all operational and advisory activities
relating to regulatory submissions worldwide, timely approvals of
product licences and subsequent licence maintenance in a
cost-effective manner; ?
* Allocate and prioritise tasks within the department to meet business
needs; ?
* Identify and address the training needs of the department; ?
* Represent the Regulatory Affairs department at Senior Leadership
Team meetings.
?_KEY RESPONSIBILITIES_ (include but not limited to): ?
* As a senior departmental member, actively contribute to the routine
operational use of, and input to, the site Pharmaceutical Quality
System by providing functional guidance and support, ensuring the
system is used according to defined procedure. ?
* Plan and execute regulatory strategies for new products to ensure
the fastest possible introduction of those products to the market,
ensure that new product development programmes are progressed with due
regard to regulatory requirements and ensure that all information
provided in submissions is of a high standard, complies with
regulatory requirements and is presented in a professional manner. ?
* Support the regulatory compliance of the company with the conditions
of its product licences and manufacturing licences. ?
* Recruit, manage and develop staff of the calibre required to meet
the present and future needs of the company. ?
* Provide an information and advisory service on regulatory affairs to
ensure all relevant personnel within the company are briefed on
current and future regulatory legislation and requirements. ?
* Represent the Regulatory Affairs Department at Senior Leadership
Team meetings. ?
* Main activities are planning; management of staff and their work;
some participation in that work; deciding on regulatory strategy and
advice to management on regulatory matters. ?
* Represent the Regulatory Department at internal and external
meetings. ?
* Propose and develop regulatory strategies for new products. ?
* Assess and advise on the quality of dossiers offered for sale by
other companies. ?
* Identify and address the training needs of the department. ?
* Allocate and prioritise work within the department to ensure the
company needs are met. ?
* Review personally or by delegation GMP documentation, including
change controls, for regulatory compliance and evaluate the regulatory
impact. ?
* Ensure departmental SOPs are maintained and complied with. ?
* Final sign-off of artwork. ?
* Monitor legislation and professional publications to maintain
awareness of current regulatory practice and advise departments on
regulatory requirements/strategy. ?
* Support to, and operational use of, the Pharmaceutical Quality
System will be achieved by monitoring and maintaining the integrity of
the Pharmaceutical Quality Systems, through implementation of
improvements and ensuring all direct reports engage with and utilise
the system in accordance with defined procedures. ?
* The job holder will participate in the provision of all metric data,
and associated required information essential for the Quality
Management Review relating to their functional area and contribute to
improving the effectiveness of the system by reporting on its
performance. In addition, they will actively participate in and
promote continuous improvements to products, processes and the
Pharmaceutical Quality System, through identification and delivery of
such enhancements, with the aim of minimising patient, customer and
business risks.
* Preparation of annual department budget
Key
_REQUIREMENTS_ include:
Educated to at least honours degree level in a life science with at
least **Apply on the website** years? experience in regulatory
affairs in an international role.
Membership of The Organisation for Professionals in Regulatory Affairs
(TOPRA) is essential.
Have an appreciation of all aspects of the working of the
pharmaceutical industry.
_ABILITY TO_ motivate and manage subordinates and colleagues.
Requires the ability to present the Company?s interests in a
professional and authoritative manner and to conduct negotiations with
regulatory bodies at the highest level.
Sees the big picture, understands key business drivers, anticipates
challenges, navigates ambiguity and complexity; keeps people focused
on the right goals.
Outstanding organisational and time-management skills.
Uses good judgement and is able to make effective decision on complex
issues despite short time lines and pressure.
Exceptional ability to leverage/collaborate effectively with internal
and external stakeholders.
Excellent written and verbal communication and interpersonal skills.
Secures resources and builds the team, system and culture needed to
meet commitments and drive results, balances short and long terms
needs and goals, and effectively leads change.
Independent, critical thinker with strong decision-making skills.
Comfortable working in a busy, fast paced regulated manufacturing
environment.
By applying to RPG Recruitment, you are consenting for your details to
be reviewed by RPG Recruitment and held on our database. If at any
stage in the future, you would like to remove your details from our
database , you can do so by requesting in writing for your details to
be removed in line with our privacy policy. RPG Recruitment operate to
the highest ethical standards of recruitment at all times
We need : English (Good)
Type: Permanent
Payment:
Category: Others
