Director - Regulatory Affairs - OPDP Liaison
Company Name:
Pharthenogene
Responsible for regulatory review, approval, and submission of all US Promotional materials to the FDA Office of Prescription Drug Promotion (OPDP).
Shall:
Manage changes to US labeling and collaboration with partners on labeling and responses supporting initial registration and communications regarding any changes to US labeling.
Provide strategic and operational leadership in advertising and promotion of new therapeutic treatments.
Develop strategies for regulatory approval and introduction of new products to market.
Ensure OPDP compliance for all approved therapeutics and promotional or marketing materials and prepare and manage corresponding reports.
Submit documents and forms such as FDA Form-2253 to the FDA Office of Prescription Drug Promotion.
Experience:
B.S. or M.S. in Scientific field; Pharm.D. or J.D. also accepted.
5
years relevant experience in pharmaceutical industry interfacing with regulatory representatives from the FDA OPDP.
Join a well established company in a leadership role with comprehensive benefits package with annual bonus, opportunity to advance, stock options, full medical, dental and vision benefits as well as long term incentives including matched 401(k) and pension.
For complete details contact Winston F. Reuning at:
(609) 584-9000 ext 230
Or submit resume online at:
Or email to:
Please reference #3609922 when responding
Education Requirements: Bachelor Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Triangle Park
Job State Location: NC
Job Country Location: USA
Salary Range: $150,000 to $230,000
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES:
Disclaimer: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.
If you submit an application or resume which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word remove in the subject line to Or, visit the website at .Estimated Salary: $20 to $28 per hour based on qualifications.
Pharthenogene
Responsible for regulatory review, approval, and submission of all US Promotional materials to the FDA Office of Prescription Drug Promotion (OPDP).
Shall:
Manage changes to US labeling and collaboration with partners on labeling and responses supporting initial registration and communications regarding any changes to US labeling.
Provide strategic and operational leadership in advertising and promotion of new therapeutic treatments.
Develop strategies for regulatory approval and introduction of new products to market.
Ensure OPDP compliance for all approved therapeutics and promotional or marketing materials and prepare and manage corresponding reports.
Submit documents and forms such as FDA Form-2253 to the FDA Office of Prescription Drug Promotion.
Experience:
B.S. or M.S. in Scientific field; Pharm.D. or J.D. also accepted.
5
years relevant experience in pharmaceutical industry interfacing with regulatory representatives from the FDA OPDP.
Join a well established company in a leadership role with comprehensive benefits package with annual bonus, opportunity to advance, stock options, full medical, dental and vision benefits as well as long term incentives including matched 401(k) and pension.
For complete details contact Winston F. Reuning at:
(609) 584-9000 ext 230
Or submit resume online at:
Or email to:
Please reference #3609922 when responding
Education Requirements: Bachelor Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Triangle Park
Job State Location: NC
Job Country Location: USA
Salary Range: $150,000 to $230,000
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES:
Disclaimer: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.
If you submit an application or resume which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word remove in the subject line to Or, visit the website at .Estimated Salary: $20 to $28 per hour based on qualifications.
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