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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
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