Senior Regulatory Affairs Specialist

hace 7 días

Barcelona, Barcelona, España Farmaprojects Sau A tiempo completo

Farmaprojects, part of Polpharma Group B.V., is a B2B Pharmaceutical Laboratory company offering a broad Portfolio of Generic Pharmaceutical Products and Value Added Medicines.

For our office in Barcelona, Farmaprojects is looking for a new Senior Regulatory Affairs Specialist to join our Regulatory Affairs Department.

At Farmaprojects, you can expect:
To be part of the transformation of the business Continuous learning opportunities A rapidly expanding company A multicultural environment open to new ideas A company culture that is a reflection of shared values You will be part of an exciting team contributing to the business whilst enjoying the following corporate benefits:
Flexible working hours Commuter benefits Ticket Restaurant Health Insurance Annual learning & development Mental healthcare support and services Team-driven celebrations and events and more

Requirements:

Specific Activities:
Assist and contribute in the development of assessments and strategic regulatory plans for strategic product planning.

Take part in the definition of Commercial Strategy since project approval until dossier submission - Target Clients/N licenses/Business Model/Go to market strategy etc Definition of Regulatory Strategy since project approval until dossier submission - Proactive MA strategy; Variation Plan if applicable Take part in the definition of D1 Launch Strategy - FTO, API etc Establish a strategic plan for priority products to maximize their performance and life-cycle; by taking part in high-level LCM strategy Support the development of initial or alternative regulatory strategies.

Manage new Marketing Authorisation applications (slot request, dossier preparation – Module 1 – and submission, procedure follow-up with Health Authorities including responses submission and product information management in local languages) in EU.

Manage variations (preparation of variations, shipment to Health Authorities (in EU), shipment to the customer & preparation of necessary responses) in EU and nonEU.

Manage renewals (preparation of Module 1 & 2, compilation and submission of the renewal documentation for Farmaproject's MAs, shipment of renewal documentation to the customer & preparation of necessary responses) in EU.

Manage other post-approval activities: Sunset clause exemption requests, withdrawal requests & post-approval commitments. Create eCTD sequences for new submissions and any post-approval activity of the lifecycle management of the product.

Maintain accurate and up to date Regulatory information on all procedure in the corresponding Regulatory database implemented in the Quality Management System of company.

Continuous developmental upgrade of knowledge with regards to the regulatory legislation in countries where Farmaprojects has clients and/or Marketing Authorisations and provide information to others when needed.

Follow up on clients and regulatory procedures all around the world. Manage any other legal/administrative documentation required such as CPPs, price reimbursement, new applications/variations/annual fees, marketing communications with the corresponding authorities etc Skills
Bachelor's or Master's degree in Life Sciences 3 -year work experience in Regulatory Affairs Department and/or Pharmaceutical Industry.

Relevant experience in Regulatory Affairs Solid understanding of the pharmaceutical industry Excellent communication skills Good knowledge of EMA, ICH and RoW regulations, guidelines, and regulatory processes regarding to drug development, approval, and maintenance of marketing authorisations.

Familiarity with eCTD submission, compilation, and publishing using specific tools. Good commercial and product awareness. Sound administrative and systems background. High proactivity and coordination skills High learning agility and open mindset for change. Ability to develop good cross-functional working relationships and tactical coordination of projects.

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