Title: Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs
HybridScientific AffairsFull time
Stockholm, Stockholm County, Sweden
OverviewApplication
Description
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 portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. 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
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
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.
