Global Regulatory Affairs Manager
vor 4 Wochen
Description of the function:
The Global Regulatory Affairs Manager will play a pivotal role in ensuring the efficacy, quality and safety of our pharmaceutical products.
The successful candidate will be responsible for overseeing the regulatory activities, managing various regulatory related processes, and ensuring compliance with regulatory requirements.
TasksIn this role, your tasks will include:
End-to-end support consisting of all activities related to Marketing Authorisation transfer (MAT) and lifecycle management of pharmaceutical products mainly in EU; that includes:
- MAT: execute the regulatory strategy; plans, prepares and delivers high-quality regulatory files to agreed timelines; responsible for the post-submission/approval activities, such as batch release change, technical transfer.
- Product lifecycle management of marketed products: responsible for the dossier compliance including CMC variations, timely regulatory filings and response to HA queries.
To that end:
- Autonomously manage regulatory activities and overseeing the day-to-day operations within the regulatory department;
- Monitor and keep abreast of the regulation and perform gap assessment as needed;
- Interact effectively with various stakeholders within the company (labelling, pharmacovigilance, quality, medical, artworks, supply chain, commercial and affiliates) and external stakeholders such as Health Authorities, third service providers.
Contribution to the RA department as follows:
- Develop, implement and update regulatory SOPs and other regulatory processes;
- Provide regulatory training to internal teams and ensure staff are updated on the latest regulations and best practices, where applicable;
- Participate in cross-functional team meetings to provide regulatory expertise;
- Participate to RA audit and self-inspection.
Qualifications:
- Master degree in Life science/Pharmaceutically-related science.
- Minimum of 5+ years of experience in global regulatory within the pharmaceutical industry; versatile experience within CMC, project management and/or CRO is advantageous.
- In-depth knowledge of global regulations and guidelines (FDA, EMA, ICH, national, etc.).
- Experience in HA interactions.
- Thorough knowledge of eCTD and CTD filing requirements, as well as global filing requirements.
- In-depth knowledge of document management best practices.
- Experience as Information Officer would be a plus.
- Good planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
- Excellent communication and interpersonal skills.
- Ability to work independently and prioritize tasks in a fast-paced environment.
- Experience in working in a matrix organization.
- Proficiency in verbal and written English; knowledge of other languages is advantageous; good computer skill.
We offer:
- A unique opportunity to work in a lean and fast paced company where you will be able to provide significant input to the regulatory department
- A full time position
- A competitive remuneration
- A dynamic and modern work environment
- Hybrid working environment, with a minimum of 2 days/week in company office in Lörrach, Germany
CHEPLAPHARM is a family-owned company headquartered in Greifswald, Germany. For more than 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for manufacturing and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia and Switzerland. The company employs around 650 people worldwide.
The affiliates in Switzerland and Lörrach, Germany were established in 2023 to further drive the growth of the group and global acquisitions of established medicines from large pharmaceutical companies.
Should you be interested in this position, please use the LinkedIn link to apply with your CV.
Please note that we will only contact shortlisted applicants.
Disclaimer: Cheplapharm does not accept unsolicited CVs from recruiters or employment agencies in response to this posting.
CHEPLAPHARM Registration GmbH, based in Lörrach (Germany), was founded in 2023 as an affiliate of the globally active CHEPLAPHARM group and as a direct subsidiary of CHEPLAPHARM Schweiz GmbH. The group’s headquarters, CHEPLAPHARM Arzneimittel GmbH, are based in Greifswald (Germany).
CHEPLAPHARM Registration was incorporated to hold the EU marketing authorizations of the products owned by CHEPLAPHARM Switzerland and is located in walking distance to the Swiss Border in Lörrach (Germany).
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