GlaxoSmithKline is looking for a Regulatory Affairs Manager.
Key responsibilities:
- Ensure timely submissions and approvals of applications for registration, confirmation of registration, and variations to registration dossier according to regulatory plan, reviewing it periodically, coordinate approval dates with key stakeholders;
- Identify possible regulatory issues (incl. changes in local requirements) and proactively communicate and escalate them, provide feasible solutions;
- Ensure alignment of registered details with original dossiers and corporate databases, timely update of the corporate databases;
- Lead written standards development and update;
- Identify areas of opportunities and risks related to regulatory activities;
- Communicate with Regulatory Authorities and provide appropriate answers to requests from Regulatory Authorities;
- Lead timely submissions of post-approval commitments;
- Implement and comply with QMS requirements in the following processes: self-inspection (L1 audit), deviation handling, CAPA management;
- Ensure regulatory support to GMP inspections;
- Foster monitoring and shaping of regulatory environment, communicate with Area Regulatory Hub and Global Regulatory Intelligence teams, analyze and provide comments on draft guidance documents for Regulatory Authorities;
- Support maintenance of the Regulatory Intelligence database;
- Manage the group of Regulatory Affairs Executives;
- Participate in appropriate trainings for improvement of professional knowledge and skills;
- Ensure back-up for Artwork and Pack Executive and Quality and Risk Management Manager (artwork proofreading process).
Requirements:
- Higher education in pharmacy / biology / chemistry;
- At least 3 years in regulatory affairs, experience of managing people or projects is preferable;
- Knowledge of regulatory policies and climate in Russia;
- Knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry;
- Insightful and forward thinking, ability to recognize, anticipate and discuss potential regulatory challenges;
- Advanced written and speaking English;
- Ability to read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquires or complaints;
- Ability to work within diverse cultures and lead multifunctional matrix teams is beneficial;
- Experience in people management; team-building and team-working skills.
What the company offers:
- Competitive salary;
- Medical insurance, life insurance;
- Meal allowance;
- Mobile compensation;
- Internal and external educational courses and trainings;
- Professional and career development opportunities (locally as well as worldwide).