Regulatory Affairs Consultant

Our client is a multinational pharmaceutical company and is looking for a REGULATORY AFFAIRS CONSULTANT to support their RA DEPARTMENT.

Location: Walloon Brabant

Duration: 6 months

Scope of work:

The Position Holder (PH) will have global responsibility (for REGULATORY AFFAIRS) of given activities for New DTP/Polio product(s)
* Involved in the Company's regulatory and administrative (including database entry) activities for this product line, basically in Europe/EMA and outside Europe (covering Emerging countries and Supranational).
* Ensure the planning/dispatch/submission/follow-up/approval of data-packages to Regulatory Authorities:
o Variations, Commitments, Questions & Answers, PSURs/PBRERs, Risk Management Plans (RMPs), Renewals, Scientific Advices & meetings with Authorities, Articles 46, Paediatric Investigation Plans (PIPs) Annual Reports, Updated files, WHO Annual Reports etc.
* Provide input into thontent of CMC SECTIONS of New DTP/Polio product specific documents submitted to regulatory agencies worldwide and ensure that these documents meet high scientific standards and regulatory requirements
* Compile/write CMC sections of regulatory dossier and Clinical Overview sections for simple life cycle submissions (eg Art.46, file update) for New DTP/Polio projects

The role includes the following responsibilities:
* Organize the planning, coordination/preparation, submission and follow-up of MAAs and of life cycle regulatory activities for the New DTP/Polio product(s) in European Union and outside EU (covering emerging countries and WHO):
o Coordinate and interact with the internal stakeholders (labelling/safety/epidemiology/clinical and technical experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
o Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fullfilled
o Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc.
o Follow-Up of submissions with Local Operating Company's (LOCs) for vaccines registered via National procedures.
* Communicate with relevant parties:
o Communicate regulatory updated information to internal stakeholders.
o Maintain close contacts with the LOCs to ensure transparent communication/update and shared objectives are achieved
o Communicate with Authorities (mainly Belgium and WHO) on administrative and procedural aspects
* Compile/write high quality CMC sections of regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements, for the New DTP/Polio product-line.
* Compile/write high quality Clinical Overview sections for simple life cycle submissions (eg Art.46, file update)
* Provide support to the line manager for key regulatory activities pertaining to the New DTP/Polio product-line.
* Good understanding and ensure alignment with regulatory legislation/guidelines, particularly related to administrative, procedural and CMC aspects.

Trainings to be followed

* On arrival - training for access to all relevant systems and focused training on preparation on regulatory documentation
* On the job - coaching on daily RA activities and on an "as-needed" basis.

Requirements:

* Master Degree or Ph.D. in the area of Pharmacy, Chemistry, Biology or Medicine

* Mininum 2-3 years RA experience in the pharmaceutical industry
* Regulatory background: procedural and CMC aspects
* Previous experience in writing scientific/regulatory documents.
* Broad knowledge is required and covers scientific as well as regulatory expertise.
* Fluent in English, with excellent writing skills.
* Able to provide regulatory input and evaluate potential impact on respective regulatory submission(s).
* Able to identify and escalate issues to the line manager.
* Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner. (teamspirit, flexibility and accountability)
* Ability to resolve problems through resourceful use of information and contacts.
* Ability to work in multi-cultural and multi-disciplinary envirement.
* Quality mindset.
* Very well organized
* Able to write and critically review documents targeting internal or external audiences.

Keywords: CMC, RA, REGULATORY AFFAIRS, RA SPECIALIST, REGULATORY AFFAIRS OFFICER