Regulatory Affairs Associate

Reposted 18 Hours Ago
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İstanbul, Fatih, İstanbul, TUR
In-Office
Junior
Software • Biotech • Pharmaceutical
The Role
The Regulatory Affairs Associate will manage regulatory compliance, support drug approvals, coordinate submissions, and maintain regulatory documentation, ensuring safety and compliance.
Summary Generated by Built In
Job Description:Regulatory Affairs AssociateAt 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.Joining our Regulatory team, you will be part of an empowering and collaborative culture where your work plays a key role in ensuring patient safety, regulatory compliance and sustainable access to medicines. By working closely with cross-functional teams and external stakeholders, you will support regulatory excellence, life-cycle management and the consistent maintenance of our portfolio. Your contribution helps ensure that high-quality therapies remain available, compliant and trusted throughout their entire life cycle.Ferring+You We are looking for a Regulatory Affairs Associate to join our team and take a key role in regulatory compliance, quality assurance, document governance, and cross-functional business support in line with local regulations and global procedures, reporting directly to the Regulatory Affairs Manager.Your day at Ferring
  • Act as Document Accountable Person (DAP) and Document Controller (DC), ensuring document lifecycle management, consistency, and compliance
  • Serve as the main local regulatory contact and manage regulatory compliance activities
  • Coordinate new drug approvals, including dossier preparation, submissions, and follow-up with local Health Authorities
  • Manage regulatory submissions, variations, renewals, and product lifecycle activities
  • Support and coordinate regulatory inspections and maintain validity of licenses and certificates
  • Monitor regulatory intelligence, assess impact, and proactively communicate regulatory changes
  • Ensure timely and accurate updates in global and local regulatory systems (e-CTD, Veeva Vault, Track Wise, etc.)
  • Prepare, review, and approve artworks and labeling to support submissions and product launches
  • Review promotional and non-promotional materials in line with local regulations and global procedures
  • Support Quality Management System (QMS) implementation and sustainability, including local market release
  • Support regulatory and pricing applications, including document coordination and pricing data monitoring
Behind our collaboration…There’s you
  • University degree in Pharmacy
  • Min. 2-3 years of practical experience in regulatory and quality assurance
  • Know-how of interactions with regulatory authorities
  • Experience with e-CTD, Veeva Vault, Track Wise, and pricing is a plus
  • Eager to learn personality, team player approach, attention to details
  • Fluent in English language (written and verbal)
People come first at Ferring
  • 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
  • Our inclusive support package – “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role
  • Parental leave for both birthing and non-birthing parents
  • Extended support on family building journey
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 youIf 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.Location:Ferring Turkey

Top Skills

E-Ctd
Track Wise
Veeva Vault
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The Company
HQ: St-Prex
5,940 Employees
Year Founded: 1950

What We Do

Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries. Community guidelines available here: https://re.ferring.com/Ferring-LinkedIn-Community-Guidelines Social Media Privacy Notice available here: https://www.ferring.com/social-media-privacy-notice/

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