Morgan Green is looking for an Interim Regulatory Affairs Manager in the pharmaceutical industry for an organization in Utrecht, the Netherlands. Are you experienced in Regulatory Affairs? Do you enjoy leading cross-functional teams? Do you have an eye for potential regulatory risks? Don't hesitate to get in contact!
This project is at a leading global company in the pharmaceutical industry.
As an Interim Regulatory Affairs Manager you will have the following responsibilities:
- Lead preparation of new regulatory documents, dossiers and applications to enable new products (medicine, devices) to be launched and maintained in the market, with the correct alignment and compliance to regulations. Lead development of strategies, policies, and mitigation plans that are aligned with business needs.
- Analyse and communicate regulatory issues, and work together with key stakeholders, including global colleagues. Build relationships with these key stakeholders and represent the organisation according to company values.
- Actively contribute to high performing teams, including looking for ways to improve performance and identifying potential regulatory risks. Lead cross-functional teams and regulatory professionals within local market.
- Manage compliance within defined portfolio/activity streams in line with company expectations - support key processes and ways of working (eg, in relation to CMC, quality, product labeling requirements, as well as CBG/MEB regulations). Propose and implement solutions to identified issues.
- Maintain required regulatory compliance databases, systems and processes. Train other company stakeholders as required to build knowledge and compliant utilization. Maintain high level of product knowledge within defined portfolio.
- A University Degree in Life Sciences
- A minimum of 5 years experience in Regulatory Affairs in a pharmaceutical industry is ideal
- Highly skilled in both spoken and written Dutch and English
- Amazing written and verbal communication skills
In case you're not a freelancer, but you are interested in this interim project, Morgan Green can arrange a payroll construction (where we take care of your payment and you will keep your social rights). For more information, please contact Marloes Bartels via 020 7979825 .
Uren per week: