VIATRIS Job Vacancies – Regulatory Affairs Executive/Assistant Manager

• Execute regulatory team activities as directed to achieve submission approval
• Coordinate with stakeholder(s) for sourcing of documents and review of executed documents received
• Experience working in European, USA, and AMEA Regulatory markets is mandatory
• Collaborate with the regulatory team to author submission documents
• Perform data entry within regulatory databases
• A preliminary review of the dossier/ submission

Viatris is a global healthcare company that provides access to medicine and invests in research and development to create innovative healthcare solutions. If you are interested in a job in Regulatory Affairs, you can check their career website or reach out to their human resources department for current job vacancies and requirements.

In general, the role of a Regulatory Affairs professional is to ensure that the company complies with all relevant regulations, laws, and guidelines related to the development, manufacture, and commercialization of healthcare products. This involves working closely with cross-functional teams, including research and development, quality, clinical, and legal teams, to ensure that products are developed, manufactured, and marketed in accordance with regulatory requirements.

The specific duties and responsibilities of a Regulatory Affairs professional may vary depending on the company and the products they work with, but they generally include:

• Reviewing and preparing regulatory submissions and applications, such as new drug applications, investigational new drug applications, and marketing authorization applications.
• Monitoring changes in regulatory requirements and providing advice and guidance to other departments on the implications of these changes.
• Conducting risk assessments and providing recommendations for managing risks associated with product development and commercialization.
• Developing and maintaining regulatory strategies for product development and commercialization.
• Ensuring that the company’s quality management system and processes comply with regulatory requirements.
• Building and maintaining relationships with regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

A successful candidate for a Regulatory Affairs role typically has a scientific or technical background, with a strong understanding of regulatory requirements and the drug development process. They should also have excellent communication and interpersonal skills, as well as the ability to work effectively in a team environment.

●Note:- Candidates with injectables -RnD or complex analytical characterization experience and willing to transition to RA are also welcome (NOT for routine analytical or validation folks).

1. Name your CV file as Your Name_Nationa RA

2. Mention Your name_Injectable RA_Your Exp in the subject

3. Mention your current CTC, expected CTC, and notice period in the mail body