Senior Regulatory Affairs Manager
- Experience Level
International Pharmaceutical Manufacturer seeks a Senior Regulatory Affairs Manager.
Duties may include:
- Deputise for the Head RA in his/her absence where relevant and appropriate.
- Proactively contribute to the continuous improvement of the performance of the Regulatory Affairs Department and actively coach members of the Regulatory team to achieve high quality output.
- Responsibility for the line management of a team of permanent members of staff. i.e. managing goals and objectives and training and development. Responsible for managing temporary staff as well as contractors.
- Overseeing all licensing activities across product range.
- Ensuring proper licensing strategies are in place for new Marketing Authorisations in defined territories.
- Ensuring proper processes and systems are in place to manage all regulatory activities related to maintaining drug licences.
- Ensuring proper and relevant documentation necessary for applications to relevant authorities is prepared, properly reviewed against authorities' requirements.
- Manage the regulatory process from interpretation of Health Authority regulations and guidance through to submission and final approval.
- Support product launch, tenders, and customers of intermediates.
- Actively maintain information data bases, documentation and procedures to ensure regulatory compliance of products released to market.
- Develop robust product licensing strategies for new products and new markets.
- Manage the regulatory aspects and licensing of Orphan Drugs within the US, EU and/or Intercontinental countries.
- Obtain Marketing Authorisations in the US, Europe countries, European Union (EU) or Intercontinental markets for designated products and manage the documentation generation process, submission, assessment, approval and product launch regulatory steps.
- Maintain existing licences (commitments, variations, renewals).
- Communicate directly with the relevant departments on the generation of any regulatory documents.
- Recommend contacting and communicate directly with health authorities about seeking advice, guidance or clarification of legal issues, dossier content or submission procedural matters. Active participation in meetings with FDA and EMA.
- Generate or supervise the generation of regulatory dossiers in eCTD format.
- Actively maintain RA data bases, documentation and procedures to ensure regulatory compliance of products released to market.
Skills and experience:
- Master's degree in Life Sciences (preference Pharmacy or Biology)
- TOPRA MSc
- Regularly attended some key Regulatory Affairs conferences and training (TOPRA, DIA).
- Min 3 years of experience of managing a team of regulatory affairs professionals
- Substantial experience in obtaining and maintaining product licenses worldwide and obtaining clinical trial authorisations in key markets (EU, US )
- Substantial knowledge of current drug regulations in key markets (US, EU,)
- Substantial experience of dealing and negotiating directly with Health Authorities in key markets (EU, US)
- Years of experience of managing EU National, Decentralised, Mutual Recognition and Centralised Procedures from strategy development to final approval and to product launch
- Experience with or solid knowledge about orphan drugs and accelerated licensing procedures in US and EU
- Strong background in CMC
- Solid knowledge of labelling procedure to ensure product labels are compliant and in line with company position
- Solid understanding of current drug regulations in key new world markets (Russia, China, Middle East)