Quality Assurance & Regulatory Affairs Specialist - Temporary position
Ferring Pharmaceuticals
Madrid, Spain
Full-Time
Competitive
RemoteSenior
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology, and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.
Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers – we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organization and as professionals. Together we can influence the world around us to make life and work better.
Ferring+You
Ferring is looking to hire a Quality Assurance & Regulatory Affairs Specialist to support and actively contribute to the area. This is a temporary position. You will be responsible for ensuring that all our products are managed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements fulfilling with Good Distribution Practices (GDP). Your primary responsibility is to ensure that effective and robust Quality Systems are in place to comply with required regulations, policies and guidelines.
We expect as well that you actively organize regulatory information, logs/tracking and issuing compliance programs for any Marketing Authorization.
Your day at Ferring
Ensuring that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines
Managing routine deviations, complaints and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product
Providing support for audits and regulatory agencies; review audit outcomes and ensure appropriate and timely corrective actions are warranted
Conduct change requests and support process modification change controls
Document Responsible Person (DRP). Management of internal SOPs system for Ferring Spain and maintain SOPs database updated
Prepare and review SOPs for regulatory and quality assurance procedures
Ensuring that initial and continuous GDP training programs are implemented and maintained
Compiling and managing regulatory applications for Ferring products to health authorities, which includes new products, product dosage forms, indication. As well as registration maintenance through renewals & variations submissions.
Providing labelling support and maintaining SPC update in the region. Reviews locally prepared labelling before approval & implementation.
Coordination, revision, and preparation of deficiency letters coming from Authorities.
Follow-up with Competent Authorities and/or vendors on any regulatory activity, until its approval and provide proper support to ensure the launch of the product.
Ensure that the regulatory database is up to date for the projects in the region (Iberia).
Behind our innovation… There’s you
Health Sciences Degree in Pharmacy, Biology, Chemistry.
Postgraduate Degree or Masters in Quality and Regulatory Affairs in the pharmaceutical industry.
2-3 years of experience in the quality department in the pharmaceutical industry, with knowledge of Quality Systems, Quality Assurance, and regulatory requirements.
Knowledge and management of SAP will be valued
Knowledge of eCTD structure for preparation of module 1. Awareness or regulatory affairs environment, EU-wide legal framework, and European authorities’ websites.
Proficient knowledge of the English language.
Quality orientation and attention to detail.
Ability to establish relationship with other departments, work in a team and adaptability skills.
Ability to organize and prioritize.
Self starter mind-set and proactivity.
Based in Madrid.
People come first at Ferring
Opportunity to learn and grow.
Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love.
Training, development, and continuous professional growth.
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions. Imagine the power of your career when it’s Ferring + You.
Behind our purpose… There’s you
If our mission and your vision are aligned, please apply!
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.
Note to agencies: this search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us spontaneous profiles.