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 Regulatory Affairs Senior Specialist to join our Regulatory Affairs Department and ready to start from January 2025!
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
* Be part of the regulatory strategies
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:
* Be responsible of 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 and Maintenance Plan
* 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
* 8 -year work experience in Regulatory Affairs Department and Pharmaceutical Industry.
* Relevant experience in Regulatory Affairs
* Solid understanding of the pharmaceutical industry (Europe, Canada, Int. Markets)
* 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.