Jun 16, 2022

Job Description

1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

Prepares and implements regulatory maintenance activities and second wave submissions to achieve targets and business objectives in accordance with the submission plan to avoid stock-outs and delayed launches. Ensures that preparation of variations follow established processes and timelines. Acts as strong business partner and project team member for maintenance/compliance matters. Builds strong interface between the local functions (NTO/ESO/QA) as well as all Sandoz development/maintenance centers to ensure continuous compliance with legal, scientific (technological), ethical and administrative requirements.

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

• Elaborates global regulatory strategies for Complex Generic product development. Participate in project/product-related discussions and provides in-depth strategic, scientific and RA input, for CMC or procedural aspects of given project.

• Planning early interactions with Health authorities like Controlled correspondences, Scientific advice, Product Development Meetings etc on complex matters requiring Agency’s opinion.

• Ensure planning and proper organization of activities in line with the overall project plan and project milestones. Ensure no delays in submission approval timelines or "first to file" opportunity losses due to gaps in the regulatory strategy and plans.

• Responsible for review of regulatory submissions (e.g. ANDS, ANDA, SNDS, NDA) and responses to Health Authority queries. Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.

• Continuously improves the quality of dossiers sent to the regulatory authorities ensuring optimal review timelines. Training and regulatory oversight

• Transfer new regulatory related information by preparing internal workshops for training of both DRC and SDC personnel. Provide regulatory training and coaching to the DRC associates, as needed.

• Participate in the development and implementation of standard operating procedures. Act as the point of contact for Global Regulatory Affairs initiatives/programs. Provides support and coordinates with relevant SDC team members. Provide support for health authority inspections.

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:
• Regulatory experience in Complex Products (viz. Oligonucleotides, synthetic peptides, Drug Device Combination Products (DDCPs)) like Pen injectors, Prefilled Syringes and ophthalmic products, for markets such as US FDA, EU/MHRA, Health Canada and Japan
• Expertise in Sterile products and microbiological sterility assurance validation documentation as per regulatory requirements
• Regulatory experience mandatory (minimum of 10 years), and/or experience in pharmaceutical industry in US, EU, Most of world market etc.
• Working knowledge of chemistry, analytics or pharmaceutical technology. Knowledge of the drug development of process desirable. Ability to critically evaluate data from a broad range of science disciplines.
• Solid knowledge of ICH, EMA, US FDA guidelines and regulatory procedures.
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
• Effective planning, organizational and interpersonal skills. Excellent written/spoken communication and negotiation skills. Good knowledge of business process and project management in development of Complex generics

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, 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 Group 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
Product Dev SZ
Hyderabad, AP
Research & Development
Full Time
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Team Lead-DRC Complex Generics

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