FDA Consultant

Position Description:

FDA Responsibilities:

- Authorized to communicate with the FDA on behalf of the establishment.

- Handle correspondence related to the FDA involving customer companies.

- Designated Correspondent for Drug Master Files (DMFs):

- File and monitor the Annual Report (administrative status report for the DMF).

- Manage current or withdrawn Letters of Authorization for FDA reference.

- File and track technical amendments.

- DMF revision and submission to the FDA.

- Annual report under the CARES Act.

- Respond to questions about drugs imported or offered for import to the United States.

- Official contact for each establishment is responsible for ensuring the accuracy of registration and listing information and respond to all communications including emergencies.

Regulatory Inspections:

- Assist the FDA in scheduling inspections and handling all communications from the FDA including emergencies.

- Provide support and/or hosting regulatory inspections.

- Assist in FDA inspection responses.

- Submit FDA inspection responses to the FDA.

Technical Issues:

- Assist with new or developing technical issues related to regulatory requirements.

- Review issues for regulatory impact before implementation and report them to the FDA or other applicable regulatory bodies.

Customer Issues:

- Review customer and customer consultant requests for accuracy validity and potential shifting of responsibility.

- Monitor and review sales agreements for FDA and DEA regulated chemicals to ensure that client manufacturing importation or distribution responsibilities or expectations are not altered without full knowledge and client acceptance.

- Review authorizations for customer companies to prevent the unauthorized use of client expertise for FDA approvals by unknown companies.

New and Updated Regulations/Guidance/Standards:

- Notify the client of new regulations with potential or definite impacts on the sale of chemicals API or other products.

Requirements include:

Position Requirements:

Any foreign establishment involved in the manufacturing preparation propagation compounding or processing of a drug imported into the United States must appoint a United States agent (U.S. agent) for that establishment as mandated by 21 CFR § 207.69 (b).

Several criteria must be met:

1. The U.S. agent must reside or maintain a place of business in the United States and cannot be a mailbox answering machine or service where the U.S. agent is not physically present.

2. If the FDA is unable to contact a foreign registrant directly information and/or documents may be provided to the U.S. agent equivalent to providing the same information to the foreign registrant.

3. U.S. agent data is published online within registration data: Drug Establishment Current Registration Site.

Skills Requirements:

- 5+ years' experience within GMP regulated facilities

- Proven track record in Quality and Compliance.

- Professional Quality Assurance Accreditation desirable

- Bachelor’s degree in a science or equivalent discipline

- Experience with Aseptic manufacture desirable

- Must understand the Food and Drug Administration (FDA) regulations for use in pharmaceuticals and medical devices to assist clients in meeting the requirements of related government agencies.

- Experience in technical writing with the ability to research complex concepts and processes and apply editing skills.

- Ability to meet the requirements of government regulations while fulfilling client goals.

- Ability to influence the client in setting goals and reaching agreement regarding the implementation of government requirements and to make important changes to work processes or business development strategies.

- Ability to form and maintain relationships with clients and government agencies.

- Must understand the changing nature of regulations as government agencies pass new laws and regulations in order to communicate to the client changes for business processes and business development strategies as needed to avoid problems such as product recalls or fraud.

- Efficient at diverse range of computer systems and applications such as office and data management tools. eCTD experience appreciated.

- Ability to apply time management skills in order to meet client and government agency requirements for regulatory product submissions and report filing.

Other Requirements:

Excellent oral and written communication skills in English/Fluent in English

Open to and able to travel domestically and internationally as required

Able to work (paid) overtime

Able to work in the US without sponsorship now or any time in the future

About CAI

CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning qualification validation start-up project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.

Meeting a Higher Standard

Our approach is simple; we put the client’s interests first we do not stop until it is right and we will do whatever it takes to get there.

As owners of CAI we are committed to living our Foundational Principles both professionally and personally:

We act with integrity.

We serve each other.

We serve society.

We work for our future.

With employee ownership one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self demonstrate Respect for Others and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.

$50 - $75 an hour

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees our customers and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).