Regulatory Affairs Senior Specialist

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Regulatory Affairs Senior Specialist, Barcelona

Client: FARMAPROJECTS SAU

Location: Barcelona, Spain

Job Category: Other

EU work permit required: Yes

Job Views: 4

Posted: 06.03.2025

Expiry Date: 20.04.2025

Job Description:

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 for 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 non-EU.
• 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 procedures in the corresponding Regulatory database implemented in the Quality Management System of the 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 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.