Regulatory Affairs Officer - Borehamwood, United Kingdom - BPL

BPL

Verified Company

Borehamwood, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

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Description

Bio Products Laboratory (BPL) is recruiting for a Senior Regulatory Officer to join the Regulatory Affairs department located in Elstree, Herts.

Reporting to the RA Manager (based in Italy), this position will be responsible for the planning and execution of regulatory affairs activities (i.e., registrations/renewals/variations) in LATAM, Balkans & CIS in line with business targets.

Headquartered in Hertfordshire, BPL invest in the latest research, technology and manufacturing methods and are continuously supplying high quality plasma-derived products worldwide.

Since privatising from the NHS in 2013, BPL has gone through huge change and growth as we aspire to be the leader in our field.

BPL is based in Elstree & Borehamwood, Hertfordshire, in a secure campus surrounded by natural beauty, lakes and wildlife.

Key duties & responsibilities -

Coordinates all regulatory affairs activities in the countries under responsibility.
Responsible for local reportability assessment of change controls, partnering with local contacts and RA Product Owners.
Responsible for planning and execution of RA activities (i.e., registrations / renewals / variations) in the geographical area of responsibility, in line with business targets.
Participates during the inspections of the Authorities of the assigned Region and ensures regulatory support.
Contributes to the proper selection and management of the providers of RA services in the assigned region.
Provides regularly updates on regulations / guidelines, etc. related to the geographical area of competence.
Provides support to the relevant Kedrion functions for local activities/requirements (i.e. tenders).
With reference to registrations, renewals and variations:
prepares the administrative sections of dossier and requests documentation, samples, reference standards from the competent functions and finalizes the regulatory package;

- analyses the questions and the commitments received from the Authorities
- assembles the whole documentation and takes care of the submission (directly or through local contacts) within the defined timelines;
- monitors the progress of the procedures with the local representatives or the competent Authorities;
- collaborates with the RA Product Owners for the maintenance of the baseline dossiers in the geographical area of its competence.

Skills & Experience to make you successful in the role -

University Scientific Degree (i.e., Chemistry, Biology, Pharmacy/Pharmaceutical Technology, Medicine).
3+ years' experience in the regulatory affairs preferably in the plasmaderived or biological/biotechnological sector
Written and spoken fluency in English.
Strong Communication skills (effective communication with internal/external stakeholders/Competent Authorities).
Teamworking skills and ability to handle multiple projects efficiently and accurately
Knowledge of Spanish language is a plus

In return we offer -