Regulatory Development Manager
Reporting to; Associate Director, Regulatory Development
Tenure; Permanent, full-time
MAIN PURPOSE:
The Regulatory Development Manager is responsible for planning and managing all regulatory activity
associated within a Therapy Area team, focused on the development and registration of new products
and complex line extensions requiring clinical and/or non-clinical research.
KEY RESPONSIBILITIES AND ACCOUNTABILITIES:
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To manage the preparation of regulatory and/or notified body submissions for Medicinal Products
and Medical Devices for those products under his/her responsibility including: clinical
trial/investigational new drug applications, scientific advice/regulatory agency/notified body
meeting documentation, global and regional new drug applications, marketing authorisation
applications or technical files as well as the preparation and filing of responses to questions from
regulatory agencies or notified bodies
To manage the preparation of high quality documentation for all regulatory submissions, following
current best practice standards
To manage own workload, including responsible delegation, to ensure agreed regulatory
timeframes are met
To liaise with relevant internal departments and external contacts to ensure regulatory
requirements for these submissions are met and to proactively communicate with regulatory
authorities in order to expedite approval of submissions.
To coordinate and lead regulatory agency meetings and internal project sub-team meetings
To advise Project Teams on applicable regulatory guidelines, project-specific regulatory issues
and matters related to the regional regulatory environment
To develop effective regulatory strategies to maximise the life-cycle opportunities of products with
new indications and variations
To communicate the impact of regulatory project plans for those products/projects under his/her
responsibility across the R&D, Business Development, and Manufacturing and Supply Chain
functions
To provide high quality regulatory advice and support to other areas of the Company
To anticipate and resolve complex regulatory issues independently
To manage submission strategy and plans
To be responsible for the information held within the Regulatory databases for his/her products
To input into and manage his/her budget, within agreed financial targets for his/her products
To be responsible for the paper and electronic filing systems for his/her products, following
Records Retention procedures
To participate in regulatory advocacy and policy activities by interaction with industry trade
associations, lobbying groups and external consultants as necessary
To represent Regulatory Affairs and/or Clinical Development within and external to Norgine
To provide strategic guidance to product development plans for those products/projects under
his/her responsibility, ensuring regulatory guidelines are interpreted to optimise product
opportunities
To monitor, plan and organise resource relevant to development projects and regulatory activities
in collaboration with the Therapy Area Programme Manager and Director
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Awareness, understanding and an ability to interpret the ICH guidelines relevant to their
technical/functional responsibilities, specifically for the technical/functional responsibilities related
to delivering a TPP at the end of the development process
Provide input into processes and procedures such as SOPs, template documents and working
guidelines. The job holder will be expected to comply with all Norgine Policies, SOPs and local
regulations as appropriate.
SKILLS AND KNOWLEDGE:
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Good degree in a relevant life science subject or equivalent, PhD desirable
Broad regulatory experience, part of which should have been gained operating at a senior level,
and good knowledge of worldwide regulatory requirements (including GMP, GLP and GCP)
A full strategic understanding of the drug development and life-cycle management principles and
processes
Demonstrates subject matter expertise, e.g. expertise in projects/therapy area/CMC/labelling, or
country knowledge
Experience in interpretation of ICH guidelines, and in development of Target Product Profiles with
the aim of delivering a product at the end of the development process
Demonstrates an ability to analyse and summarise data to a high level
Good awareness of external regulatory environment
Line management experience
Focuses on Commercial needs
Focuses on customer needs, follows up on commitments and requests
Excellent interpersonal skills
Excellent verbal and written communication skills
Leadership skills
Works cooperatively within a team and leads team as appropriate
Works effectively without supervision
Exercises considerable autonomy in decision making and objective setting
Ability to communicate clearly in English.
Closing date; 20th January 2016.