Team Lead Pharma Submissions

5 days ago

Stockholm, Stockholm, Sweden Karo Group Full time

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.

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

Team Lead 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
  • Coordinating Regulatory Intelligence
  • Contact person for eCTD Publishing
  • Supporting Head of Global Regulatory Affairs with budgeting and follow up
  • Responsible for Submissions & Compliance SOPs and associated instructions
Portfolio responsibilities:
  • 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

Minimum 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

What We Offer:

  • 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.

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