Team Leader for CHC Regulatory Advisors, acting as a key coordinator of overall CHC activities and point of contact with CHC Product Development Head and Regulatory Affairs function leadership
Recommending and cascading goals consistent with the directions of the business development strategy
Preparation of budget assumptions in the area of responsibility (within the Registration Department)
Foster a collaborative and innovative team culture, emphasizing professional development and knowledge sharing.
Provide guidance to team members managing day-to-day pro activities.
Verification and support in recommending the best registration strategies for CHC
Market and regulatory insights:
Providing pragmatic guidance and insights to cross-functional CHC product development project teams, on how their decisions might impact registration/notification and timelines, and contributing to project risk - benefits assessments
Continuous improvement of qualifications, including monitoring changes in the law and guidelines related to the scope of conducted tasks.
Reporting and risk management.
Contribution to Polpharma Continuous Improvement:
Caring for company values (acting together, with openness and with responsibility) in a proactive approach to work.
Responsibilities as development project Team member:
Cooperating with other organizational units within the Polpharma Group structures and its external partners (including licensors) as well as representatives and agents in the countries within the scope of their activities, based on mutual respect and high quality.
Regulatory Documentation and Procedures:
Preparing registration/notification documentation for food supplements, medical devices, and cosmetics
Conducting registration/notification procedures
Responsibility for ensuring that the technical documentation is drawn up and kept up-to-date in scope of responsibility of person responsible for regulatory compliance according to Article 15 of REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017.
Requirements:
Degree in a relevant field (within Life Sciences: pharmacy, chemistry, biotechnology or others complemented with relevant post-graduate studies and experience)
Minimum of 4 years of experience in regulatory affairs in CHC / FMCG sector.
Experience in managing regulatory affairs teams in leading Pharma CHC, Consumer Healthcare or FMCG companies.
Good knowledge of legal requirements for CHC medicinal products and standards for medical devices, food supplements, cosmetics.
Experience working with cross-functional teams.
Cross-functional Teamwork spirit, ability to adapt fast and comfort with change.
Consumer Centricity and Consumer/ CHC understanding.
Understanding of innovation and how regulatory affairs can support.
Fast to market mindset.
Calculated Risk-Taking.
Strong communication and collaboration skills
Very good command of English, allowing for smooth communication.
We offer:
Employment contract
Private medical care
Life insurance
Multisport card
Training and development of professional competences
