Regulatory Partner

Job description

The Position

Regulatory Partner

Roche Central Asia is looking for a committed Regulatory Partner with a structured and growth mindset.' We offer a challenging and varied job in an active and flexible working environment, where you will have responsibility for handling regulatory tasks and outcomes.  You will also become part of an innovative and extremely dynamic organization.

Role purpose

The role performs the coordination and preparation of document packages for regulatory submissions in Kazakhstan for new and registered products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company as well as internal audits and inspections. Contribution to Regulatory Policy shaping.

Accountability for Kazakhstan. 

Reports to Science Chapter Lead

Key areas of responsibility:

● Regulatory Life Cycle Management: lead of registration process of already registered and new products (National\EAEU procedure)

● Create and drive a regulatory strategy for the products in zone of responsibility

● Coordinate artworks changes related to Lifecycle Management, make sure corporate regulatory data and document management systems are up to date

● Keeps abreast of regulatory legislations, procedures and changes to the regulatory landscape to secure compliance at all times.

● Maintain and develop relationships with Health and Regulatory authorities, associations.

● Implement new systems in regulatory affairs.

● Maintain of procedures to secure compliance to regulatory legislation.

● Drive and develop relationship within Roche:

- business and disease area teams

- Supply Chain, Patient Journey Partners, Healthcare System Partners, Medical Affairs, Drug Safety, Finance, etc.

- EAEU Hub and Roche HQ

Requirements\ qualifications

● You have a master's degree in pharmacy, pharmaceutical sciences or related fields.

● Have a strong personality and thrive to work in a regulated area

● Systematic in your way of working, you are flexible and you have strong interpersonal skills

● Team player with growth mindset,  that can work both independently and cooperate effectively with others

● Fluent English in both speech and writing

● Embrace changes and seek to optimize processes

We also value the following skills:

● Evaluating problems (Examining Information, Documenting Facts, Interpreting Data)

● Structuring tasks (Developing expertise, Adopting Practical Approaches, Providing Insights)

● Communicating information (Convincing people, articulating Information, challenging ideas)

● Giving support (Understanding people, team working, valuing individuals)

● Processing details (Meeting timescales, checking things, following procedures)

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.