Head of Regulatory Affairs - Newry, United Kingdom - Norbrook Laboratories

Norbrook Laboratories

Verified Company

Newry, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

In Norbrook we pride ourselves in being one of the top companies in Northern Ireland and one of
the top veterinary pharmaceutical companies globally. We develop & manufacture veterinary
medicines, supplying products to 120 countries globally. With a strong portfolio of existing products
and significant investment in R&D to launch new products annually, we have opportunities for
individuals to join us and develop their career in a global company.

Our business strategy is supported by our Values - Customer Value, One Team, Results Driven,
Excellence, Innovation, and Quality - and we support our employees to live the behaviours that
creates our culture. Our on-going success is based on the expertise, knowledge and innovation of
our employees. If you are interested in joining our team here at Norbrook and supporting our vision,

Job Overview
responsibility for the entire product portfolio (new products and existing (marketed) products) in all
countries excluding North America. This is a critical role for the company, with the successful
relevant regulatory requirements around the world.

**Main Activities

Define & implement regulatory strategies and submissions for the company's existing broad

portfolio of products and for new products in the pipeline, supporting the company's future
growth strategy

Manage positive professional relationships with regulatory authorities, maintaining and

improving Norbrook's reputation with regulatory authorities (outside North Amercia)

Lead the development and implementation of innovative strategies to maximise the likelihood

of regulatory success

Lead the Regulatory Affairs Team with responsibility for all markets outside North America,

driving productivity improvements, high standards of performance, and challenging the status
quo to support future business growth

Ensure compliance with postmarket approval regulatory obligations and maintenance of

licenses/authorisations for existing products, including review/approval of internal
specifications, evaluation of changes in product or processes to determine regulatory impact

Accountable for ensuring the company is up to date on all relevant national and international

legislation (outside North America), guidelines and regulatory practices and remains
compliant to regulations at all times

Gain regulatory intelligence from global markets and share internally to develop best practice
Identify continuous improvement within the regulatory team, ensuring compliance is adhered

to at all times

Act as lead Regulatory Affairs representative on the Change Control Board

products to ensure existing dossiers reflect current practice

Ensure the Regulatory strategy for New Products supports rapid approval with advantageous

labelling and successful commercialisation on time

Actively participate in relevant Regulatory inspections
Lead the preparatory activities for interactions with regulatory authorities, lead or colead

face to face meetings and liaise and negotiate with international regulatory agencies

Develop Risk Assessments and action plans as required based on regulatory agency outcomes

Essential Criteria:

order to be considered:

Educated to degree level in a relevant qualification, and/or minimum of 5 years' experience

in a regulated environment

Demonstrable ability to lead a team, driving high standards of performance, developing talent,

and managing underperformance as required

Minimum 15 years in a regulatory affairs management position, preferably in the

pharmaceutical industry overseeing the regulatory approval of new and existing products in
the UK, Europe, and other territories

Excellent communication skills: coupled with the ability to influence and develop positive

stakeholder relationships.

Ability to work crossfunctionally, keeping all stakeholders informed of forthcoming

regulatory changes and ensuring all current activities comply with regulations.

Have a proactive, cando attitude to be resolution driven.

Desirable Criteria:

Due to the nature of the role preference will be given to applicants demonstrating the following

desirable criteria:

Experience in the animal health pharmaceutical sector
Experience in a generics pharmaceutical company

Duration:
Full time, permanent.

Location:
Newry

Remuneration:
Salary Attractive

Benefits:
Free Life Assurance, Company Pension Scheme, 31 days annual leave, Wedding Leave,
Employee well-being initiatives, Healthcare plan, Company Sick Pay, Employee Assistance
Programme, On-site free parking, Canteen Facilities, Employee Perks scheme, Discounted Car
Insurance, Annual Employee raffle, employee recognition scheme, career development
opportunities and much more

Contact:
The Human Resources Department