Pharma Submission Lead

9 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time
Job Description

At TN Sweden, we are seeking a highly skilled Pharma Submission Lead to join our Global Regulatory Affairs team. In this role, you will be responsible for overseeing the submission and compliance process for our medicinal products.

  • Key Responsibilities:
  • Personnel responsibility and competence development for the Submissions & Compliance group
  • Securing a dedicated and motivated team to drive maintenance and development of Karo medicinal products
  • Resource allocation
  • Accountable for the management of Submissions & Compliance activities including strategies, submission planning and performance

Requirements:

  • University degree in Life Science - Good understanding of regulatory requirements and applicable legal frameworks
  • Minimum of 5 years experience in Global Regulatory Affairs in a similar role
  • Record of formal or informal leadership qualities
  • Extensive record of Variation management

What We Offer:

  • A dynamic and growing company with a wide-ranging portfolio across seven categories
  • Opportunity to create, grow, and encourage
  • Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
  • Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Why Join Us?

We believe in empowering people to make intelligent health decisions and driving growth through innovation and collaboration. Our team is diverse and inclusive, and we are committed to creating a positive work environment where everyone can thrive.



  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a highly skilled Pharma Compliance Manager to join our Regulatory Affairs team in Stockholm, Sweden. As a key member of our team, you will be responsible for ensuring compliance with relevant regulations and developing strategies for successful submissions.Main ResponsibilitiesRegulatory Compliance and Strategy:Accountable for the management...


  • Stockholm, Stockholm, Sweden Karo Group Full time

    Our CultureAt Karo Healthcare, we strive to create a collaborative, innovative, and dynamic environment where talented individuals can thrive. We believe in fostering open-mindedness, encouraging individual initiatives, and promoting cross-functional collaboration. As a result, we offer a stimulating atmosphere for professionals seeking challenging roles,...


  • Stockholm, Stockholm, Sweden Planet Pharma Full time

    Planet Pharma is partnered with a leading biotech firm, leveraging monoclonal antibodies in transplantation and autoimmunity research.About the RoleWe are seeking an experienced Senior Biologics Manufacturing Lead to join our team at our site in Sweden.


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Job SummaryWe are seeking a detail-oriented Medical Product Submission Specialist to manage our global submissions and compliance efforts. In this role, you will work closely with cross-functional teams to ensure timely and accurate submission of regulatory documents.Key Responsibilities:Creating and/or review of regulatory documentation as relevant for...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Are you a seasoned patent attorney with expertise in the pharma sector? Do you have a passion for helping clients protect their commercial ambitions?We are seeking a highly skilled Senior European Patent Attorney to join our Stockholm-based pharma team at TN Sweden. As a key member of our dynamic team, you will be supporting SMEs and larger pharma companies...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Job OverviewTN Sweden is a leading intellectual property practice with a strong focus on the pharma sector.As a patent attorney, you will play a key role in creating value from innovations and ensuring that our clients' patents are properly protected.ResponsibilitiesClient Support: Work closely with clients worldwide to support them in successful filing and...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Job SummaryAs a Senior Director of Regulatory Affairs, you will be responsible for shaping regulatory strategies and building a new pharma portfolio for a leader in consumer health. This role requires a strategic leader with a business-minded approach to ensure compliance and promote innovative solutions.About the CompanyOur client is one of the leading...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    PharmaRelations ApS is committed to delivering exceptional services to our clients in the life sciences sector. As a Pharma Relations Medical Expert, you'll play a vital role in shaping our company's mission by providing accurate medical information and leading teams to achieve outstanding results.Your key responsibilities will include supporting a team of...

  • Transformation Lead

    3 days ago


    Stockholm, Stockholm, Sweden TN Sweden Full time

    Unlock Productivity and Enhance Customer ExperienceCelonis is a pioneer in process mining technology, and we are seeking a skilled Business Development Strategist to join our team.As a key member of our team, you will develop and execute business strategies to drive growth, expand customer relationships, and enhance the adoption of our solutions.Key...


  • Stockholm, Stockholm, Sweden Haeger & Carlsson | Executive Search & Interim AB Full time

    Executive Search & Interim AB - Partnering with Haeger & CarlssonWe are seeking a seasoned Regulatory Affairs Director to join our client's dynamic team. In this pivotal role, you will drive global regulatory strategies to ensure the timely submission and approval of biologic products.The successful candidate must have a strong background in regulatory...


  • Stockholm, Stockholm, Sweden Cencora | Pharma solutions Full time

    Cencora | Pharma solutions is a leading provider of pharmaceutical solutions and is seeking a highly motivated and results-driven Sales Growth Strategist to join our team. As a Sales Growth Strategist, you will be responsible for developing and executing sales strategies that drive revenue growth and expand our customer base.About the Company:Cencora |...


  • Stockholm, Stockholm, Sweden Cencora | Pharma solutions Full time

    Cencora | Pharma solutions is seeking a seasoned Sales Growth Strategist to spearhead business development efforts in Sweden. As a key member of our team, you will be responsible for driving sales growth and expanding our customer base.Job Description:The ideal candidate will have a proven track record of success in business-to-business sales, with a strong...


  • Stockholm, Stockholm, Sweden Planet Pharma Full time

    Job Description:The successful candidate will provide comprehensive CMC support for internal projects, from GLP toxicology through IND/CTA clinical programs to post-approval NDA/BLA.Main Responsibilities:Ensure timely supply of Drug Substance/Drug Product for non-clinical and clinical studies.Collaborate with internal and external teams in analytical/quality...


  • Stockholm, Stockholm, Sweden FNZ (UK) Ltd Full time

    As a Regulatory Reporting Lead, you will be responsible for overseeing the submission of regulatory reports and trade surveillance data from upstream client order management and trading systems.Key ResponsibilitiesOversight of daily monitoring of transaction reporting across all regulations supported, including EMIR, MiFIR, ASIC, and MAS.Oversight of daily...


  • Stockholm, Stockholm, Sweden ALSTOM Gruppe Full time

    Technical Bid ManagerAt Alstom, we understand the complexity of transport networks and what drives innovation in mobility. From high-speed trains to signalling systems, we offer our diverse customers a broad portfolio of solutions that enhance safety and efficiency. Every day, 80,000 colleagues lead the way to greener and smarter mobility worldwide,...


  • Stockholm, Stockholm, Sweden Rittal Danmark Full time

    Company OverviewWe are a world-leading provider of life science facilities, with our headquarters in Stockholm City. Our company brings engineering and project solutions that make a difference and has been a pioneer in bringing the modular facility concept to the pharmaceutical industry since its founding in 2010.We provide services to a global customer...


  • Stockholm, Stockholm, Sweden Haeger & Carlsson | Executive Search & Interim AB Full time

    Haeger & Carlsson Executive Search & Interim AB - A Global PartnershipWe are proud to partner with a pioneering life sciences company to identify a talented Biologics Licensing Expert. As a key member of the leadership team, you will lead global regulatory strategies to support the submission and approval of biologics.The ideal candidate has a proven track...


  • Stockholm, Stockholm, Sweden Haeger & Carlsson | Executive Search & Interim AB Full time

    Haeger & Carlsson Executive Search & Interim ABWe are partnering with a renowned life sciences company to find a highly skilled Director Regulatory Affairs. As a key member of the leadership team, you will develop and execute global regulatory strategies to support the submission and approval of biologics.The ideal candidate has a proven track record in...


  • Stockholm, Stockholm, Sweden Alfa Laval Corporate AB Full time

    As a Shipbuilding Project Lead at Alfa Laval Corporate AB, you will be responsible for coordinating customer projects and ensuring timely delivery of our wing sails onboard large oceangoing vessels.Key responsibilities will include project implementation coordination, feasibility studies, conceptual study initiation, approval procedures support, and process...


  • Stockholm, Stockholm, Sweden Randstad Full time

    Job SummaryWe are looking for a skilled Software Development Lead to oversee the development of software products. The successful candidate will have a strong technical background and excellent leadership skills.Key Responsibilities:Lead the development team to deliver high-quality software products.Collaborate with stakeholders to identify and prioritize...