Current jobs related to Director of Regulatory Affairs and Compliance - Stockholm, Stockholm - PharmaRelations ApS

  • Regulatory Affairs Director

    3 hours ago

    Stockholm, Stockholm, Sweden beBee Careers Full time

    **Job Title:** Senior Director Regulatory AffairsWe are seeking an experienced Senior Director Regulatory Affairs to establish and lead regulatory strategies, particularly for OTC products, as we build our pharmaceutical portfolio.This is a unique opportunity to join a pioneering team where you'll shape the future of OTC pharmaceuticals. As a senior leader...

  • Regulatory Affairs Expert

    3 hours ago

    Stockholm, Stockholm, Sweden beBee Careers Full time

    This role offers a unique opportunity to excel in regulatory affairs and drive compliance for medical devices across the globe.Job DescriptionDevelop and maintain product registrations for new and existing products, ensuring seamless commercial supply and product maintenance.Act as the primary contact for RA activities, including regular meetings with...

  • Regulatory Compliance Manager

    2 weeks ago

    Stockholm, Stockholm, Sweden Sobi, Inc Full time

    Job RoleThe Global Regulatory Compliance Lead is a key role within Global Regulatory Affairs, responsible for leading Regulatory Compliance activities, including procedural document creation and updates, audit and inspection execution and preparation, and regulatory risk management.Responsibilities:Lead assigned Regulatory Compliance work and improvement...

  • Compliance Regulatory Expert

    2 weeks ago

    Stockholm, Stockholm, Sweden Sobi, Inc Full time

    Sobi, Inc. OverviewWe are a global company dedicated to developing and delivering innovative therapies to improve the lives of people who live with rare diseases.Job DescriptionThe Global Regulatory Compliance Lead will lead assigned Regulatory Compliance activities, including procedural document creation and updates, audit and inspection execution and...

  • Regulatory Affairs Sr. Associate, Nordics

    2 weeks ago

    Stockholm, Stockholm, Sweden Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Regulatory Affairs Lead

    2 weeks ago

    Stockholm, Stockholm, Sweden Sobi, Inc Full time

    Our CultureAt Sobi, we refuse to accept the status quo and strive to create solutions that serve the needs of those affected by rare diseases.Job DetailsThe Global Regulatory Compliance Lead will lead Regulatory Compliance activities, including procedural document creation and updates, audit and inspection execution and preparation, and regulatory risk...

  • Regulatory Affairs Professional

    3 hours ago

    Stockholm, Stockholm, Sweden beBee Careers Full time

    This position requires a highly skilled and experienced Regulatory Affairs Professional to manage and oversee compliance matters related to electric vehicle systems and charging infrastructure.Key Qualifications:Proven experience in a compliance role within the automotive industry.Experience with electric vehicle systems and/or charging infrastructure.Strong...

  • Regulatory Affairs Manager

    4 weeks ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    Are you a communicative and detail-oriented person with the drive to navigate the complex landscape of regulatory and marketing compliance?You now have an opportunity to join a dedicated and committed Regulatory, QA & PV team under expansion, which is a key function within the Medical department at Nordic Infucare. To succeed in the role of Regulatory...

  • Sr. Associate Regulatory Affairs Role, Nordics

    2 weeks ago

    Stockholm, Stockholm, Sweden Eli Lilly and Company Full time

    Sr. Associate Regulatory Affairs Role Overview">We have an exciting opportunity to join our Nordic Regulatory Affairs team.This role encompasses a broad range of regulatory activities across the Nordic countries and can be tailored based on your prior experience and interests.

  • Regulatory Compliance Specialist

    2 weeks ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    Are you a detail-oriented individual with excellent communication skills, seeking to join a dedicated team in the Medical department at Nordic Infucare? As our new Regulatory Affairs Manager, you will be responsible for developing regulatory strategies, monitoring policies, and collaborating with cross-functional teams.The company has extensive expertise in...

Director of Regulatory Affairs and Compliance

2 weeks ago

Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

Regulatory Affairs Director Job Summary

We are seeking an experienced Senior Director Regulatory Affairs to join our team at PharmaRelations ApS. In this role, you will be responsible for establishing and leading regulatory strategies, particularly for OTC products, as we build our pharmaceutical portfolio.

Key Accountabilities

  • Take ownership of regulatory activities across a range of areas, including MAs (MRP/DCP and national licenses).
  • Oversee the marketing of cosmetics, medical devices, and food supplements across the Nordics.
  • Collaborate with the MAH's global team and local colleagues to develop and implement regulatory strategies tailored to the Nordic region.
  • Critically evaluate submission packages to meet Nordic regulatory standards, eliminating deficiencies prior to submission.
  • Monitor and influence the assessment process to expedite approvals and optimize outcomes, including product labeling and supply continuity.
  • Ensure compliance by communicating any regulatory changes to the global team and addressing critical issues such as batch recalls or release challenges.
  • Submit and maintain local medicinal product information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs, and Educational Material as needed.
  • Lead the management of new MA submissions in collaboration with the global team, supporting Scientific Advice meetings, launches, and readiness initiatives.
  • Provide strategic regulatory advice for divestments and in-licensing opportunities, considering Nordic-specific perspectives.

Requirements

  • Education: Life Science Degree or equivalent, with broad regulatory experience in medicinal products. Experience in food supplements, cosmetics, and medical devices is advantageous.
  • Experience: Minimum of 10 years in regulatory activities, with a focus on OTC products and commercial aspects within the pharmaceutical industry.

What We Offer

  • A competitive compensation and benefits package.
  • A flexible, hybrid work environment promoting innovation and collaboration.
  • Opportunities for professional development and leadership in building a regulatory team.