Novo Nordisk job vacancy for Regulatory Professional I at Bangalore, Karnataka
Regulatory Professional I
Category: Reg Affairs & Safety Pharmacovigilance
Location: Bangalore, Karnataka, IN
Department: Global Regulatory Affairs
Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to ensure the life cycle management of Novo Nordisk’s medicines by regulatory authorities across the globe. Regulatory Affairs is a fast-changing field where no two days are alike, and the engaged employees in our unit need a unique combination of scientific insight and the ability to navigate tight deadlines and many stakeholders. Apply now and join a growing team, working in an international environment.
Position 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 and submit pre-meeting packages for authority meetings.Handle change requests.Submission of regulatory files, response to health authorities and maintenance of marketing authorizations worldwide.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.
Qualifications6-8 years of experience in related field along with Post Graduate Degree is required.International Work experience or previous experience with working in a global setting. Qualifications. (from recognised platform will be an add on).Experience in handling health authorities/government bodies/local market authorities is must.Experience in handling life cycle management of product is required.Experience in handling Clinical regulatory submissions is required.Global exposure in terms of handling different markets.Team/people management experience is an add-on.Excellent communication and presentation skills.Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup
Contact
If you believe you are a match for the above requirements and are highly motivated to take up the role, please apply here with our online application tool.
Deadline
Apply on or before: 24 November 2023
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