Regulatory Affairs Manager (Fluent in English and Mandarin (Nantong Dialect)
Siegfried USA LLC
Location: Pennsville, New Jersey
Type: Full Time
Salary: Up to $90K
Asian Regulatory Affairs
Worldwide Regulatory Affairs
Telecommuting is allowed.
Internal Number: PSV Reg Affairs
Responsible for managing Regulatory Affairs for the US facility and fulfill US Agent responsibilities for all foreign Siegfried sites. Responsible for managing/supporting US and China drug master files for the US and Global Siegfried API facilities. Support registration activities for Siegfried in China, through our Chinese affiliate or local agents.
Support maintenance of FDA Drug Registrations, FDA Substance Listings, and State Licenses.
ESSENTIAL DUTIES 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.
Ensures 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 RA colleagues.
Review and Assess Change Controls.
Submit FDA Registration and Drug Listings globally.
Pay FDA Facility fees and DMF fees for all sites 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.
When applicable, support/review customer’s regulatory submissions for accuracy (exclusive’s products).
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.
Maintain ~50 state licenses.
Gather required information and submit renewal application with fees before license expires.
Maintain a list of active state licenses with expiration dates
Review and stay current with any changes to state regulations.
Research and apply for new licenses as necessary.
Provide technical support for Customer Service by:
Manage Customer Request System for Pennsville products. Act as a support role for customer requests for foreign sites for products that are being imported into the US.
Maintaining regular correspondence with Sales Director in order to stay informed about upcoming contracts with customers, which may require a government agency filing.
Stay familiar with Global (EU, ICH, China) and FDA guidelines including, but not limited to, Changes to an NDA/ANDA, SUPAC, Drug Listing and Registration regulations, FDA import requirements, pertinent CFR sections, pertinent ICH Guidelines (including Q7).
Utilize US FDA and China NMPA/CDE websites on a regular basis to research current project guidelines.
Adhere to all applicable SHE and cGMP regulations.
EDUCATION AND EXPERIENCE:
A BA/BS degree in chemistry, biology, or equivalent.
Experience in pharmaceutical environment/regulatory affairs from 2-4 years.
Knowledge of cGMP's.
Fluent in English and Mandarin (Nantong Dialect)
Must have good communication skills.
Must be very conscientious and detail-oriented.
Must have excellent computer skills (MS Office).
Must be a team player, and able to work cross-functionally and across sites (virtual team settings).
Must be a self-starter and initiator.
Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.
Pennsville is our drug substance manufacturing site for the US market and provides spray drying operations globally.
- Pilot and commercial manufacturing of drug substances (APIs) and related intermediates
- ll fully cGMP and SHE compliant
- 3 GMP pilot suites: 0.1–2 m³ reactors
- 200m3 commercial capacity: 1–10 m³ reactors
- Successful transfer of new products to the commercial scale - Powerful rectification
- Spray drying in pilot and commercial scale for both isolation and dispersion technology
- Micronization in pilot and commercial
- Strategic importance
CMO for innovative drug substances and manufacturer of our opiates portfolio for the US market