Regulatory Affairs Lead - Office of Prescription Drug Promotion Liaiso
Seeking individual with extensive knowledge of FDA regulations and compliance requirements for promotional and advertising materials related to pharmaceutical products.
Key Functions:
- Provide regulatory expertise to teams comprised of Legal representatives, Medical Affairs members and Marketing groups.
- Interface with individuals from the FDA Office of Prescription Drug Promotion.
- Serve as primary point of contact between the FDA and company, communicate new and updated regulatory requirements to team members and verify compliance.
- Analyze documents and promotional materials to identify and correct mistakes that could extend submission process.
- Direct the submission of approved promotional materials to the FDA using Form-2253.
Requirements:
- Bachelor of Science or Master of Science degree, PharmD or JD.
- 3
years experience in pharmaceutical regulatory
- Ability to interact with top-level regulatory committees and representatives from the FDA and internal stakeholders from various teams.
Leadership role in a global provider of unique and specialized therapeutic solutions. Internal growth opportunities and external interaction with high-profile individuals in government regulatory agencies. Competitive compensation package with attractive salary and bonus, company paid benefits, paid time off, travel reimbursement and expense account. Perquisites include matched 401(k), long term incentives such as pension and retirement plan as well as company stock holdings.
For complete details contact Winston F. Reuning at:
(609) 584-9000 ext 230
Or submit resume online at:
http://dmc9.com/wfr/app.asp
Or email to:
1000018929_10007281(at)jobbank301.com
Please reference #3609913 when responding
Education Requirements: Master Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Cheshire
Job State Location: CT
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: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Pharmaceutical Regulatory Affairs Director Head Advertising Lead Marketing Specialist Pharma Advertising Regulatory Affairs Representative Label Promotion Review OPDP Office Of Prescription Drug Promotion FDA Form 2253 Ad/Prom Pharma Advertising & Promotion
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 pleaseremove(at)candseek4.com Or, visit the website at www.jobbankremove.com. If you have further concern regarding email received from us, call (609) 584-5499.Estimated Salary: $20 to $28 per hour based on qualifications.
Key Functions:
- Provide regulatory expertise to teams comprised of Legal representatives, Medical Affairs members and Marketing groups.
- Interface with individuals from the FDA Office of Prescription Drug Promotion.
- Serve as primary point of contact between the FDA and company, communicate new and updated regulatory requirements to team members and verify compliance.
- Analyze documents and promotional materials to identify and correct mistakes that could extend submission process.
- Direct the submission of approved promotional materials to the FDA using Form-2253.
Requirements:
- Bachelor of Science or Master of Science degree, PharmD or JD.
- 3
years experience in pharmaceutical regulatory
- Ability to interact with top-level regulatory committees and representatives from the FDA and internal stakeholders from various teams.
Leadership role in a global provider of unique and specialized therapeutic solutions. Internal growth opportunities and external interaction with high-profile individuals in government regulatory agencies. Competitive compensation package with attractive salary and bonus, company paid benefits, paid time off, travel reimbursement and expense account. Perquisites include matched 401(k), long term incentives such as pension and retirement plan as well as company stock holdings.
For complete details contact Winston F. Reuning at:
(609) 584-9000 ext 230
Or submit resume online at:
http://dmc9.com/wfr/app.asp
Or email to:
1000018929_10007281(at)jobbank301.com
Please reference #3609913 when responding
Education Requirements: Master Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Cheshire
Job State Location: CT
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: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Pharmaceutical Regulatory Affairs Director Head Advertising Lead Marketing Specialist Pharma Advertising Regulatory Affairs Representative Label Promotion Review OPDP Office Of Prescription Drug Promotion FDA Form 2253 Ad/Prom Pharma Advertising & Promotion
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 pleaseremove(at)candseek4.com Or, visit the website at www.jobbankremove.com. If you have further concern regarding email received from us, call (609) 584-5499.Estimated Salary: $20 to $28 per hour based on qualifications.
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