342858BR
Apr 29, 2022
India

Job Description

200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.

Your Responsibilities:
Your responsibilities include but not are limited to:

• Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.

• Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies.

• Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions.

• Serves as a regulatory liaison on the project team throughout the product lifecycle.

• Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices.

• Serves as regulatory representative to marketing or research project teams and government regulatory agencies.

• Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What You’ll bring to the role:

Experience with regulatory submission and approval processes in 1 or more major regions.
• Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry. Experience in HA negotiations.
• Understanding of post-marketing/brand optimization strategies and commercial awareness preferred.
• Involvement in a dossier submissions and approvals.
• Drug regulatory submission and commercialization in region.
• Analysis and interpretation efficacy and safety data. Regulatory operational expertise.
• Strong interpersonal, communication, negotiation and problem solving skills.

Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re
proud of this, we know there is so much more we could do to help improve and
extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found
at the intersection of medical science and digital innovation. That a diverse,
equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned
by integrity, curiosity and flexibility. And we can reinvent what's possible, when we
collaborate with courage to aggressively and ambitiously tackle the world’s
toughest medical challenges. Because the greatest risk in life, is the risk of never
trying!

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
REG AFFAIRS GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
careers default image
342858BR

GPRM/Sr.GPRM

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