Team Lead Pharma Submissions

2 days ago

Stockholm, Stockholm, Sweden Karo Healthcare Full time
Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs

Karo Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A. Since 2019, under EQT ownership, we're rapidly heading towards a €1 billion European leadership position in consumer health.

Join us at Karo Healthcare on our exciting journey. We're currently looking for a Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs for our headquarter office in Stockholm, Sweden.

Tasks and 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
  • Ensuring compliance with and oversight for the artwork process as well as with Karo relevant eRIMS data system and archiving
  • Oversight of SPOR and implementation in Karo's data systems from RA perspective
  • Coordinating and supporting local RA consultants to ensure compliance with local requirements such as local databases, compendial etc. in line with Karo processes
  • Contact person for eCTD Publishing
  • Supporting Head of Global Regulatory Affairs with budgeting and follow up
  • Responsible for Submissions & Compliance SOPs and associated instructions
  • Ensuring adequate and timely planning, preparation, submission and follow up of regulatory procedures and associated regulatory tasks for the assigned portfolio, while bearing in mind cross-functional impact, securing communication as needed
  • Creating and/or review of regulatory documentation as relevant for submissions
  • Maintaining current knowledge base of existing and emerging regulations, standards, or guidance documents
  • Providing regulatory input to cross functional teams/projects
  • Coordinating subsidiaries, partners and consultants on applicable market(s)
  • Coordinating Product Information translations, ensuring updates of applicable national databases and product monograph websites

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
  • Experience from artwork maintenance and associated label requirements
  • Experience from National procedure, DCP and MRP within the European Union. Global RA experience is meritorious
  • Record of cross-functional duties and interactions (within Scientific Affairs, towards Operations and commercial functions as well as external stakeholders and partners of different sorts)
  • Strong working relationship/experience with regulatory authorities
  • High-level understanding of CMC is meritorious but not a requirement
  • Fluent in English
  • Solution-oriented, flexible and good communication skills with the ability to look at issues from different angles, and challenge status quo, striving to offer solutions
  • Good at calibrating standards of work and seeing the big picture
  • Ability to independently organise, sequence, prioritise and carry out given tasks including decision making as necessary
  • Openminded and appreciative towards an evolving and dynamic workplace where cross-functional collaboration and own initiatives are key

Benefits

  • Opportunity to create, grow, and encourage
  • Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
  • 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
  • Very positive work environment in a dynamic, international, and motivated team
  • Start-up spirit while being a part of the large international organization with strong values

Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.

Seniority level

Director

Employment type

Full-time

Job function

Management

Industries

Non-profit Organizations and Primary and Secondary Education

#J-18808-Ljbffr

  • Pharma Submissions Manager

    2 days ago

    Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Role SummaryThis is an exciting opportunity to join Karo Healthcare as a Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs. The successful candidate will lead the Submissions & Compliance group and be responsible for developing and implementing strategies for submission planning and performance improvement.Main ResponsibilitiesLead the...

  • Global Compliance Lead

    2 days ago

    Stockholm, Stockholm, Sweden Karo Healthcare Full time

    About the RoleKaro Healthcare is a leader in the healthcare industry, with a strong focus on empowering individuals to make informed health decisions. As a Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs, you will play a critical role in ensuring compliance and efficient submissions processes.Key AccountabilitiesProvide leadership to the...

  • Healthcare Regulatory Expert

    2 days ago

    Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Job DescriptionThe Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs will be responsible for leading the Submissions & Compliance group and overseeing their development. The successful candidate will also develop and implement strategies for submission planning and performance improvement, collaborate with stakeholders, and maintain...

  • Regulatory Affairs Director

    2 days ago

    Stockholm, Stockholm, Sweden Karo Healthcare Full time

    Job OverviewKaro Healthcare, a dynamic and rapidly growing company, is at the forefront of making informed health decisions for everyday healthcare. With an extensive portfolio across multiple categories, including medical products, we own and sell over 80 brands in approximately 90 countries. Our core mission is to empower individuals with smart choices for...

  • Nordic Commercial Product Manager OTC

    3 days ago

    Stockholm, Stockholm, Sweden Avia Pharma AB Full time

    Direct message the job poster from Avia Pharma ABHead of Nordics at Avia Pharma | Certified Board memberAre you a driven and strategic marketer with experience in product management within OTC and healthcare? Do you want to work in a dynamic environment where you can influence and develop the marketing of strong brands? Avia Pharma is now looking for a...

  • Commercial Product Manager for OTC Portfolio

    3 days ago

    Stockholm, Stockholm, Sweden Avia Pharma AB Full time

    About the RoleAs a Commercial Product Manager at Avia Pharma, you will lead marketing activities in the Nordics for our OTC assortment.ResponsibilitiesDrive sales and margin growth in line with the marketing strategy.Analyze market trends and take action to optimize sales and profitability.Plan and execute ATL and BTL activities to support business...

  • Life Sciences Consultant

    60 minutes ago

    Stockholm, Stockholm, Sweden Galderma Pharma S.A Full time

    Galderma Pharma S.A. is a world-leading dermatology company that offers a range of innovative, science-based products and services. As a Life Sciences Consultant, you will play a key role in providing expert scientific and clinical support to healthcare professionals.The ideal candidate will have a deep understanding of life sciences and experience in...

  • Medical Dermatology Specialist

    60 minutes ago

    Stockholm, Stockholm, Sweden Galderma Pharma S.A Full time

    Galderma Pharma S.A. is a leading dermatology company that delivers innovative, science-based products and services across Aesthetics, Consumer Care, and Prescription Medicine. As a Medical Dermatology Specialist within our organization, you will be responsible for providing expert scientific and clinical support to healthcare professionals.The ideal...

  • Head of Marketing for Avia Pharma OTC

    3 days ago

    Stockholm, Stockholm, Sweden Avia Pharma AB Full time

    About the PositionThis is a unique opportunity to join a dynamic and growing company as a commercial product manager.You will be responsible for leading marketing activities in the Nordics for our OTC portfolio.The role involves working closely with our licensing partners to maximize business potential.Responsibilities include developing and implementing...

  • Medical Science Specialist, Angelini Pharma

    7 days ago

    Stockholm, Stockholm, Sweden Medhouse Full time

    We are looking for a highly skilled and experienced Medical Science Specialist to join our team at Angelini Pharma. The successful candidate will provide medical expertise and support to healthcare professionals and key opinion leaders across the Nordics.This role requires a strong background in medical affairs and a minimum of 5 years of experience in the...

  • Rare Disease Portfolio Lead

    9 hours ago

    Stockholm, Stockholm, Sweden Kyowa Kirin Full time

    About Our ValuesAt Kyowa Kirin International plc, we're guided by four core values: Teamwork, Commitment to Life, Innovation, and Integrity. These values empower us to push boundaries and deliver extraordinary results while making Kyowa Kirin a fantastic place to work.We take pride in being an inclusive organization that takes the time to understand what...

  • Pharmaceutical Industry Professional

    60 minutes ago

    Stockholm, Stockholm, Sweden Galderma Pharma S.A Full time

    We are seeking a Pharmaceutical Industry Professional to join our team at Galderma Pharma S.A. As a member of our Medical Scientific Liaison team, you will be responsible for providing scientific and clinical support to healthcare professionals.The ideal candidate will have a medical, pharmacy, biology, or chemistry degree qualification and relevant...

  • Salesforce Business Transformation Lead

    3 days ago

    Stockholm, Stockholm, Sweden Capgemini Full time

    About the OpportunityThis is a unique chance to shape the future of technology leadership in the Nordics as Head of Nordic Salesforce Center of Excellence.Key HighlightsBe part of one of the top 5 global Salesforce partners, shaping the Nordic go-to-market strategy and building CxO relationships.Play a crucial role in developing winning proposals across our...

  • Konsultchef inom QA Pharma till GBA Key2Compliance

    60 minutes ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    Vi erbjuder en spännande möjlighet att kombinera strategiskt ledarskap med operativa bidrag i en snabbt växande organisation.Som Konsultchef inom QA Pharma kommer du att leda den strategiska utvecklingen av affärsområdet, med sikte på en årlig tillväxt som överstiger marknadstrender. Du kommer att stärka och utöka relationerna med våra kunder...

  • Scientific Liaison Expert

    60 minutes ago

    Stockholm, Stockholm, Sweden Galderma Pharma S.A Full time

    As a Scientific Liaison Expert at Galderma Pharma S.A., you will play a key role in providing scientific and clinical support to healthcare professionals. This position involves developing and maintaining professional relationships with internal and external customers, including physicians and extenders.The ideal candidate will have a medical, pharmacy,...

  • Corporate Social Responsibility Lead

    6 days ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    Our Commitment to SustainabilityAt Instabee, we are dedicated to making a positive impact on the environment and society. We believe that sustainability is essential to our business model and core values.The Role and ResponsibilitiesWe are seeking a skilled Sustainability Controller to join our team. The successful candidate will be responsible for leading...

  • Vi söker en säljande Konsultchef inom QA Pharma till GBA Key2Compliance AB

    2 hours ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    Vi söker en säljande Konsultchef inom QA Pharma till GBA Key2Compliance AB, StockholmGBA Key2Compliance erbjuder kompletta och optimerade lösningar inom regelefterlevnad för Life Science-branschen.Din bakgrund:Är du en visionär ledare som brinner för att driva tillväxt och skapa värde i en dynamisk och innovativ miljö? Key2Compliance söker en...

  • Proposal Development Lead

    4 days ago

    Stockholm, Stockholm, Sweden CatalystOne Solutions Full time

    CatalystOne Solutions is expanding its sales team and is looking for a skilled Proposal Development Lead to manage and optimize the bid process. As a key member of our sales department, you will play a crucial role in shaping how we respond to complex proposals.About the RoleThe successful candidate will be responsible for leading and project managing bid...

  • Product Management Lead in Nordics

    3 days ago

    Stockholm, Stockholm, Sweden Avia Pharma AB Full time

    We are seeking an experienced and skilled commercial product manager to join our team in the Nordics.About the JobThis role is responsible for leading marketing activities in the Nordics for our OTC portfolio.You will be working closely with our licensing partners to maximize business potential.Responsibilities include developing and implementing marketing...

  • Engineering Team Lead

    3 days ago

    Stockholm, Stockholm, Sweden Sinch Full time

    Engineering Team LeadAbout Our ApproachWe believe in a two-way process and encourage you to ask questions throughout the journey. We are committed to ensuring a fair, objective, consistent, and inclusive recruitment process.Key ResponsibilitiesYou will lead a team of developers in Stockholm, collaborating with your Product Partner to plan and build the right...