Job Title:

CMC specialist in Regulatory Affairs for medicinal products for human use

Syntrion GmbH is seeking a highly motivated, experienced, and detail-oriented individual to join our team in the field of Regulatory Affairs (full-time / part-time) (m/f/d)

Company Description:

Syntrion GmbH is a reputable and specialized company founded in 2001 that focuses on regulatory affairs expertise for medicinal products. With expertise in herbal, homeopathic, allopathic, biological and biotechnological products, Syntrion GmbH offers a comprehensive suite of services for marketing authorization processes. The company's dedication to innovation has been recognized with an Award for Particularly Innovative Achievements in 2012, highlighting their commitment to staying at the forefront of advancements in authorization processes for pharmaceuticals. Role Description:

This is a full/part-time on-site role as a Regulatory Affairs Specialist located in Calw. After basic orientation, you will prepare regulatory-relevant documents for national and international new submissions, variation notifications, and renewals in the highly regulated field of the authorisation of herbal, homeopathic, allopathic, biological and biotechnological medicinal products. Your responsibilities will be in the following topics:

• CMC documentation of Module 3 Quality (Drug Substance, Drug Product), ASMF, CEP and Module 2.3 Quality Overall Summary for application of marketing authorisations, variations including transfer of manufacture
• Compilation and the maintanance of CTD Module 3 Quality (Drug Substance, Drug Product)
• Management of post-approval quality changes
• Classification of quality related variations (Grouping, Worksharing process)
• Development of innovative strategies for submitting complex variations

You will use our eCTD software to submit applications independently to national and international authorities. For your projects, you will correspond with authorities, customers, laboratories, and manufacturers. Your profile:

You are best suited to us if you have a degree in the natural sciences (e.g., biology, biotechnology, pharmacy, chemistry, biochemistry, food chemistry, etc.) and ideally proficient experience in the field of drug approval. You enjoy working independently and within a team, precisely and carefully, and have the ability to manage multiple projects concurrently, as well as dealing with ever-changing challenges. You are confident in using MS Office and have very good command of written and spoken English skills. Your strengths include initiative, flexibility, and confidence in dealing with new things. Our offer:

We offer you an innovative working environment with flat hierarchies and independent areas of responsibility. In our new company building, we offer you a special workplace environment with ergonomic writing desks, a ventilation system for allergy sufferers, an attractive lounge area with a kitchen, free access to drinks and foods, and your own employee parking space, as well as flexible working hours for a good work-life balance. If the aforementioned working conditions resonate with your values and expectations, we confidently assert that Syntrion is the ideal workplace for you to grow and thrive professionally. To apply for this position, please submit your resume and a cover letter outlining your interest in regulatory affairs and why you believe you would be a good fit for this position. Applications can be sent, preferably by email to r.ullmann@syntrion.com (https://mailto:r.ullmann@syntrion.com) .

Exeptional and inclusive environment at Syntrion GmbH:

At Syntrion GmbH, our employees are privileged to work in an exceptional and inclusive environment that places equal emphasis on productivity and employee well-being. The company provides individual office spaces for each team member, ensuring privacy and focus when required. Upon joining Syntrion, new employees receive dedicated mentoring support to facilitate a smooth transition into their roles and acclimate to our company culture. At Syntrion, teamwork is encouraged among professionals with diverse backgrounds and expertise who collaborate effectively to foster innovation and creativity. At Syntrion, we pride ourselves on our flat organizational hierarchy, which encourages open communication and promotes a sense of equality among all team members. This structure enables us to create a collaborative environment where everyone’s opinions and contributions are valued.

At Syntrion, we prioritize the well-being and satisfaction of our employees by offering flexible working hours, which enables them to effectively manage their professional and personal lives. Our versatile ergonomic desk is designed to prevent back pain issues and can be adjusted to your preferred height for both sitting and standing work positions. We understand the importance of a healthy work-life balance and strive to create an environment that supports it. To enhance convenience for our team members, we provide designated parking spaces, making their commute to and from work as seamless as possible. This perk not only saves time but also reduces the stress associated with finding suitable parking. Our well-appointed kitchen facilities allow employees to prepare meals and snacks throughout the day, fostering a comfortable and homely atmosphere. We also provide free coffee, snacks, fruits, and internet access for enjoyment during break times. This feature encourages staff to take breaks, socialize, and recharge during their workday. Recognizing the need for relaxation and rejuvenation, we have designated areas within our premises where employees can unwind and de-stress. This space promotes mental well-being and helps maintain a positive work environment. At Syntrion, we are committed to accommodating the needs of all employees, including those with allergies. Our air exchange system ensures a healthy and comfortable workspace for everyone, reflecting our dedication to inclusivity and employee health.

If you possess a strong commitment to precise working quality, Syntrion extends an invitation for you to join our team. If the aforementioned working conditions resonate with your values and expectations, we confidently assert that Syntrion is the ideal workplace for you to grow and thrive professionally.

Bereitgestellt in Kooperation mit der Bundesagentur für Arbeit.