DirecciónFarmaprojects, 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.
Hace 7 horas
