Sr Regulatory Affairs Manager
Sr Regulatory Affairs Manager
Posted on :
20-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Sr. Regulatory Affairs Manager
Job Location: Pennsville Township NJ USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
At its locations around the world Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach coupled with our dynamic working environment make 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.
Candidates for this role are eligible for remote work under Siegfried's work from home policy. The successful candidate can be located in either Pennsville New Jersey or Grafton Wisconsin
Further tasks and responsibilities:
Siegfried's work environment is dynamic and international. With a highly professional and motivated team the company operates in a futureoriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible diverse and discriminationfree working environment in which employees can develop personally and professionally advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by locationspecific circumstances legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API) intermediates and finished dosage forms. As our core competence we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality efficiency flexibility and safety. Present in Europe Asia and North America we serve a broad global customer base from major international pharmaceutical companies down to small biologicpharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from earlystage Research & Development services such as synthesis scaleup formulation development stability studies and method development all the way through to manufacturing services ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover we produce 20 percent of global demand for caffeine. Consequently nearly 1 billion individuals come into contact with Siegfried products.
What we do in Zofingen
Zofingen is the hub of the Siegfried Group. The production facility at our Zofingen headquarters supplies our customers around the globe with exemplary Swiss quality. The Siegfried company is a popular employer in the Zofingen region where we meet our social responsibility by training apprentices.
Main activities
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.
Candidates for this role are eligible for remote work under Siegfried's work from home policy. The successful candidate can be located in either Pennsville New Jersey or Grafton Wisconsin
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 online 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
- 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 detailoriented. This position requires someone who has a selfstarter and initiator mentality.
Siegfried's work environment is dynamic and international. With a highly professional and motivated team the company operates in a futureoriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible diverse and discriminationfree working environment in which employees can develop personally and professionally advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by locationspecific circumstances legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API) intermediates and finished dosage forms. As our core competence we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality efficiency flexibility and safety. Present in Europe Asia and North America we serve a broad global customer base from major international pharmaceutical companies down to small biologicpharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from earlystage Research & Development services such as synthesis scaleup formulation development stability studies and method development all the way through to manufacturing services ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover we produce 20 percent of global demand for caffeine. Consequently nearly 1 billion individuals come into contact with Siegfried products.
What we do in Zofingen
Zofingen is the hub of the Siegfried Group. The production facility at our Zofingen headquarters supplies our customers around the globe with exemplary Swiss quality. The Siegfried company is a popular employer in the Zofingen region where we meet our social responsibility by training apprentices.
Main activities
- Development and commercial manufacture of active pharmaceutical ingredients (APIs) and corresponding intermediates
- Fully compliant with cGMP and SHE (Safety Health and Environmental) standards
- Manufacture of high potency active ingredients in development and production
- Micronization in development and production
- Contract manufacturing of new active ingredients
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Employment Type
Full Time
Key Skills
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