Sr. Regulatory Affairs Manager

At its worldwide locations, Siegfried offers its employees exciting career opportunities in an international environment. We foster multidisciplinary collaboration and encourage our employees to actively shape and influence their careers. This approach, combined with our dynamic work environment, makes Siegfried an attractive employer.

Your Role

In this versatile and diversified role, you are responsible for managing our Regulatory Affairs for the US facility and fulfill US Agent responsibilities for all foreign Siegfried sites. Additionally, you will be managing all drug master files for the US facilities and maintain FDA Drug Registrations, FDA Substance Listings, and other similar requirements If you live by the values of excellence, passion, integrity, quality and sustainability, you will love working for Siegfried.

Further tasks and responsibilities:

• Prepare regulatory documentation for assigned products for submission to the regulatory agencies or customers
• Submit CMC Drug Substance Submissions, prepare eCTD files and transmit through regulatory on-line portals
• Ensure compliance to regulatory guidance's, regulations, as well internal policies
• Work with subject matter experts internally in a timely manner to respond to questions from health authorities
• Provide regulatory guidance to departments or project teams regarding development, evaluation or validation of drug substances
• Develop global regulatory strategies and execute product changes in close cooperation with global Regulatory Affairs
• Review and Assess Change Controls
• Submit FDA Site Registrations and Drug Substance & Product Drug Listings for all Siegfried globally
• Assist with gathering information for responses to deficiency letters, track responses with various experts within other company departments to ensure a timely response to FDA
• Provide technical support for Customer Service (e.g. act as a support role for customer requests for foreign sites for products that are being imported into the US)
• Imports/Customs: Review End Use Letters in a timely manner from customers for accuracy and ensure it meets FDA import requirements, assist with technical support for FDA in order to clear customs and avoid detentions/returns

Your Profile

• Education: BA/BS degree in chemistry, pharmacy, biology, or equivalent
• Language: Fluent in English
• Work experience: 5+ years in a similar position
• Industry experience: Experience in pharmaceutical environment including interactions with FDA. Knowledge of cGMP's is a must.
• Who we are looking for: We would like to welcome a colleague who is a team player and has outstanding communication skills. In addition, you are very conscientious and detail-oriented. This position requires someone who has a self-starter and initiator mentality.

Working at Siegfried

The working environment at Siegfried is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried has a unique culture that leverages cultural differences to gain a competitive advantage. Siegfried places the highest value on a flexible, diverse, and discrimination-free work environment where employees can develop personally and professionally, drive innovation, and deliver top performance. We strive to create a work environment where employees can take on challenging tasks and associated responsibilities that best serve their personal and professional development and benefit from the success of our company. The company policies regarding compensation and development opportunities apply equally to all Siegfried locations. Additional working conditions depend on site-specific circumstances, legislation, and customs.

Who We Are

In the midst of people's lives - across the world The Siegfried Group is one of the world's leading Custom Development and Manufacturing Organizations (CDMOs) that develop and produce pharmaceutical active ingredients (API), intermediates, and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical expertise into a single business model. The name Siegfried stands for highest quality, efficiency, flexibility, and safety. With locations in Europe, Asia, and North America, we serve a broad global customer base, from large international pharmaceutical companies to small biologic-pharmaceutical companies. For them, we develop and produce product innovations on a large scale up to the finished product. We seamlessly integrate our offering into the customers' value chain. Our comprehensive range of services extends from early research and development services such as synthesis, scale-up, formulation development, stability studies, and method development to manufacturing services ranging from preclinical R&D material for clinical trial purposes to commercial production. We are capable of manufacturing about 200 of the approximately 1500 registered drugs used in medicine. In addition, we produce 20 percent of the global demand for caffeine. Nearly 1 billion people come into contact with Siegfried products.

What We Do in Zofingen

At our headquarters in Zofingen, we develop and produce active pharmaceutical ingredients (API) and corresponding intermediates. This also includes the production of highly potent active ingredients. Furthermore, we offer chemical process development as well as pharmaceutical services. We supply our global customers with exemplary Swiss quality and operate fully in compliance with cGMP and SGU standards.