Job Description

• 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.
• 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.
• 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 to clear customs and avoid detentions/returns.
• Development and commercial manufacture of active pharmaceutical ingredients (APIs) and corresponding intermediates.

• BA/BS or master's degree in chemistry, pharmacy, biology, or equivalent.
• 5+ years of Experience in pharmaceutical environment including interactions with FDA.
• Knowledge of cGMP's is a must.
• We would like to welcome a colleague who is a team player and has outstanding communication skills.
• Manufacture of high potency active ingredients in development and production.
• Micritization in development and production.
• Contract manufacturing of new active ingredients.
• Fully compliant with cGMP and SHE (Safety, Health and Environmental) standards.
• Develop global regulatory strategies and execute product changes in close cooperation with global Regulatory Affairs.

Job Tags

Similar Jobs