Senior Scientific Affairs Manager (m/f/d) for our location Moscow
CHEPLAPHARM is a global and fast-growing speciality pharmaceutical company with an exceptional, sustainable business model. Our mission: To be THE platform for established and trusted branded products in various therapeutic areas and indications and to ensure their availability in the highest quality as an important partner of the innovation-driven pharmaceutical industry for the global market!
We have a common goal: to improve people's health and lives. That's why we don't think in terms of quick results. We want to achieve more with our actions - in the long term and reliably.
All of this is only possible with people who don't just do their job but want to achieve something themselves. We are so successful because we develop and encourage our colleagues and give them the flexibility they need for their daily work.
We are filling this position at our location in Moscow, Russia.
If you want to be part of our success story, we look forward to receiving your application!
Your Tasks:
- You will support the management of EAEU marketing authorisations and overall pharmaceutical products for Russia and, if required, also for the EAEU in cooperation with local colleagues, the office in Germany and partners.
- You are responsible for the compliance of Russian locally manufactured products as well as products manufactured abroad with the relevant legislation (RU national and EAEU).
- You manage and coordinate local projects as well as local partners and manufacturers.
- You will review regulatory requirements, coordinate the timely transfer of information to the organisation and support the development of submission strategies for approval changes.
- You will support the preparation and submission of electronic change notifications to the local authority.
- You are the contact person for authorities and for our national and international partners.
- You check our production documentation against the approval documents for conformity and initiate corrective measures if necessary.
- You will provide advice and support in the areas of technology transfer, import licences and GMP inspections.
- You will be responsible for the coordination, planning and implementation of local pharmaceutical expertise in the context of annual and random controls and regulatory procedures.
- You will plan and coordinate the procurement of all materials required for local expertises.
Your Profile:
- You have successfully completed a scientific or technical degree.
- You have several years of relevant professional experience in the pharmaceutical industry and in the supervision of RU/EAEU marketing authorisations as well as in the quality sector.
- You are solution-orientated and work with a high level of commitment and conscientiousness.
- You like to take responsibility and make target-orientated decisions, which you have already demonstrated in the past.
- You have experience in project management and project coordination.
- You communicate confidently in Russian and English and have the ability to work in intercultural teams.
- You are characterised by a structured, organised and conscientious way of working.
- You have an independent yet team-orientated working style and proactive thinking skills.
Our Offer:
- Agility and significant and continuous company growth
- Direct and open corporate culture
- Diverse and open-minded working environment with employees from around 40 different countries
- Number of holidays in accordance with the Russian labour legislation
- Internal and external training tailored to your personal goals
- Company events
We look forward to receiving your application! Please only use the 'Apply now!' button for your application.
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