Regulatory Professional

6 years

Preffered by Company

Bangalore

2 July 22, 2024

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Professional

Job Details

Job Title: Regulatory Professional
Location: Bangalore, India
Department: Regulatory Affairs Rare Blood Disorders
Job Category: Reg Affairs & Safety Pharmacovigilance
Application Deadline: 22nd July 2024

Job Description

Are you passionate about driving regulatory strategy and life cycle management of a product portfolio while ensuring interactions with regulatory authorities across the globe? Do you thrive in a multidisciplinary environment requiring a unique combination of scientific insights and the ability to navigate tight deadlines and multiple stakeholders?

We are looking for a Regulatory Professional to join our Regulatory Affairs team at Novo Nordisk. If you are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.

The Position

As a Regulatory Professional, you will:

Demonstrate leadership by setting regulatory strategies and being responsible for planning, preparing, and submitting high-quality files to health authorities to achieve fast approvals.
Work as an integrated part of global cross-functional teams with stakeholders ranging from safety, medical affairs, and commercial to our Novo Nordisk affiliates worldwide.
Plan and drive regulatory activities and deliverables according to agreed timelines and quality standards.
Be accountable for specific deliverables such as submission and approval of clinical trial applications, preparation of meeting packages for Health Authorities, conducting Health Authority interactions, and obtaining regulatory approvals globally.
Demonstrate subject matter expertise within regulatory science, including knowledge about regulatory processes and activities related to global Life Cycle Management (LCM) activities.

Responsibilities

Compile, review, and submit pre-meeting packages for authority meetings.
Handle change requests and submission of regulatory files, responses to health authorities, and maintenance of marketing authorizations worldwide.
Plan and conduct regulatory interactions with health authorities, including preparing meeting requests and packages and taking meeting minutes.
Manage pharmacovigilance documentation, such as Drug Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), renewals, and post-approval changes.
Oversee Life Cycle Management (LCM) of the product, including clinical file protocols and interim study reports.

Qualifications

6+ years of experience in a related field with a Post Graduate Degree in Life Sciences.
International work experience or previous experience working in a global setting is preferable.
Experience in handling life cycle management of products 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 with excellent communication, negotiation, and presentation skills.
Understanding of business management and the R&D 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.

About the Department

The Regulatory Affairs department at Novo Nordisk plays a crucial role in ensuring compliance and patient safety. Our team works closely with relevant authorities and stakeholders throughout the product development lifecycle. With diverse academic and professional backgrounds, our team brings valuable insights and expertise to the table. We offer excellent opportunities for professional development and career growth in a dynamic and challenging environment.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are expanding massively and reaching millions around the world, impacting more than 40 million patient lives daily. This success relies on the joint potential and collaboration of our more than 63,000 employees worldwide. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk means working toward something bigger than ourselves; it’s a collective effort. Join us! Together, we go further. Together, we’re life-changing.