RA Manager

Sandoz•Princeton, NJ

1d•$114,100 - $211,900•Hybrid

About The Position

An exciting opportunity to join the Sandoz biosimilar team and be part of bringing affordable medicines to patients and prescribers. The individual will support the US Biosimilar Regulatory Affairs team and will work with various project teams on licensed products as well as products in development. The individual will be responsible for the operational execution of specific regulatory deliverables relating to worldwide maintenance, upkeep and lifecycle management of Sandoz biosimilar products on a continual or ad-hoc basis. Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Requirements

Bachelor in a science required
3-5 years experience in regulatory affairs, preferably in biosimilars area
Knowledge of existing and upcoming industry trends and regulatory changes.
Demonstrated understanding of relevant regulations and standards from highly regulated agencies such as the FDA, EMA, and MHRA
Proficiency in data analysis and regulatory document preparation.
Experience with HA meetings and communications
Fluent English required (oral and written)

Nice To Haves

Ability to work independently, under pressure, demonstrating initiative and flexibility.
Team spirit and embracing diversity of cultures and personalities.

Responsibilities

Participates in Global RA project meetings & provides input into global strategy for US submissions.
Is responsible for implementing the agreed upon strategies for assigned projects
Prepare US eCTD documents & facilitating timely submissions and approvals to support the biosimilar pipeline
Management of high-quality regulatory documents and tracking of regulatory activities in relevant IT systems to support team deliverables.
Maintain regulatory archive systems.
Support local regulatory requirements such as preparation of NDC forms, annual reports, etc to ensure compliance with regulatory health authorities.
Determines requirements and sets objectives for Health Authority (HA) interactions as applicable.
Coordination of key regulatory information between various departments and participates in launch preparation activities.
Execute and manage operational activities for assigned projects.