As a Senior Regulatory Professional, you are expected to demonstrate leadership by setting the regulatory strategy and being responsible for planning, preparing, and submitting high quality files to the health authorities achieving fast approvals
- You will work as an integrated part of global cross-functional teams with stakeholders ranging from safety, medical affairs, commercial to our Novo Nordisk affiliates worldwide
- As part of our department, you will be responsible for planning and driving regulatory activities and deliverables according to agreed timelines and quality
- You will be accountable for specific deliverables such as submission and approval of clinical trial applications, driving and coordinating preparation of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory approvals globally
- You must demonstrate subject matter expertise within regulatory science including but not limited to profound knowledge about regulatory processes and activities related to global Life Cycle Management activities
Furthermore, in the role you will also handle: -
Compile, review, submit pre-meeting packages for authority meetings and Handle change requests.
Submission of regulatory files, response to health authorities and maintenance of marketing authorizations worldwide.
Plan and conduct regulatory interactions with health authorities, including preparing meeting requests, packages, and taking meeting minutes.
Pharmacovigilance documentation like Drug Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Risk Management Plan (RMP), renewals, post approval changes.
Handle Life Cycle Management (LCM) of the product, keeping the product live- clinical file protocols and Interim study reports.
Qualifications
9-12 years of experience in related field along with Post Graduate Degree in Life Sciences is required.
International Work experience or previous experience with working in a global setting will be preferrable.
Experience in handling life cycle management of product and clinical regulatory submissions is required.
Thorough understanding of regulatory science and requirements across various regions including EU, US, China, Japan, and others.
Experience in label development, health authority interactions, and device development.
Proficiency in regulatory intelligence and therapeutic area knowledge.
Demonstrated project management skills. Excellent communication, negotiation, and presentation skills.
Understanding of business management and the RD value chain in the pharmaceutical industry.
Familiarity with digital health, competitive intelligence, disease understanding, statistics, pharmacovigilance, non-clinical and clinical pharmacology.
Knowledge of patient access, real-world evidence, and proficiency in written and spoken English.
