Drug Regulatory Affairs Specialist

6+ years years

Preffered by Company

Bangalore

2 July 11, 2024

Job Description

Job Type: Full Time Education: Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences (B.V.Sc.) 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

Job Title: Drug Regulatory Affairs Specialist

Job Description

Location: Bangalore, India

Job Category: Regulatory Affairs & Safety Pharmacovigilance

Department: Regulatory Affairs Rare Blood Disorders

Overview: Are you passionate about driving regulatory strategy and managing the life cycle of a product portfolio while interacting with regulatory authorities globally? Do you thrive in a multidisciplinary environment that requires a unique combination of scientific insights and the ability to navigate tight deadlines and multiple stakeholders? If so, we invite you to join our Regulatory Affairs team at Novo Nordisk. This is an exciting opportunity for a Regulatory Professional to make a significant impact in a challenging and rewarding role.

The Position: As a Regulatory Professional, you will be responsible for setting the regulatory strategy and managing the planning, preparation, and submission of high-quality files to health authorities for fast approvals. You will work as an integrated part of global cross-functional teams with stakeholders ranging from safety, medical affairs, and commercial teams to Novo Nordisk affiliates worldwide.

Key Responsibilities:

Plan and drive regulatory activities and deliverables according to agreed timelines and quality.
Submit and gain approval for clinical trial applications and regulatory files.
Drive and coordinate the preparation of meeting packages for Health Authorities and conduct Health Authority interactions.
Handle Life Cycle Management (LCM) of the product, including clinical file protocols and interim study reports.
Compile, review, and submit pre-meeting packages for authority meetings and handle change requests.
Maintain marketing authorizations worldwide and respond to health authorities.
Prepare and conduct regulatory interactions with health authorities, including meeting requests, packages, and minutes.
Manage pharmacovigilance documentation such as Drug Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and Risk Management Plans (RMP).

Qualifications:

6+ years of experience in the regulatory field and a Post Graduate Degree in Life Sciences.
International work experience or experience in a global setting is preferable.
Experience in handling life cycle management of products and clinical regulatory submissions.
Thorough understanding of regulatory science and requirements across various regions, including the 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 and 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 growing and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. Our success relies on the collaboration of over 63,000 employees worldwide. We value the unique skills and perspectives our employees bring and continuously work to bring out the best in them. Join us in our collective effort towards something bigger than ourselves.

Contact: If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

Deadline: Apply on or before 22nd July 2024.

Disclaimer: It has been brought to our attention that there have been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. These false employment offers may request personal information, purchasing of equipment, or funds to further the recruitment process. Be advised that Novo Nordisk does not extend unsolicited employment offers, charge prospective employees with fees, or make requests for funding as part of the recruitment process.

Commitment to Diversity and Inclusion: At Novo Nordisk, we recognize that it is not enough to aspire to be the best company in the world; we must aspire to be the best company for the world. This is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are committed to creating an inclusive culture that celebrates diversity. Together, we’re life-changing.