Here are the top opportunities available for Regulatory Affairs and Regulatory Operations experts to interview for in the New Year. Our clients are looking to hire candidates to add to their teams in 2017.

Regulatory Affairs eCTD Submissions Specialist - $120k - Mansfield, MA

Requires experience leading submission of INDs, NDAs, ANDAs, BLAs, Master Files, etc. formatted according to FDA eCTD requirements.

Regulatory Liaison and Document Submission Specialist - $115k - Waltham, MA

Requires direct industry experience in Regulatory Operations with specific expertise in eCTD submissions and FDA defined formatting requirements for submission and filing packages.

Regulatory Affairs Operations Manager - Clinical Trials - $130k - Danvers, MA

Experience with managing regulatory submissions to FDA and expertise with electronic common technical document (eCTD) format as well as the FDA Electronic Submission Gateway. Must have expert knowledge of submission requirements for INDs, NDAs, Master Files (MF), PAS (Post Approval Studies), PSUR (Periodic Safety Update Reports), MAA (Marketing Authorization Applications)

eCTD Submission Lead - Drug Development Document Publishing - $140k - Burlington, MA

Seeking individual with direct experience managing the compilation, formatting, review, and hypertext linking, of submissions to the FDA in eCTD (electronic Common Technical Document) format.

Regulatory Operations Specialist - FDA Submissions - $125k - Lexington, MA

Seeking experience in Regulatory Operations for pharmaceutical drug development, medical device development, or similar with ability to lead the internal transition from paper based flings to eCTD (Electronic Common Technical Document) formats for regulatory submissions.

Regulatory Affairs Manager - Biologics - $150k - Cambridge, MA

Requires leadership experience within regulatory affairs focused on biologic drugs.

Director, Regulatory Affairs - Medical Devices - $200k - Boston, MA

Seeking individual to lead the Regulatory Affairs team within a medical device manufacturer. Requires regulatory submission and approval experience for Class II or III med devices.

Regulatory Affairs Director - Labeling, Advertising, Promotion - $190k - Medford, MA

Requires leadership experience in pharmaceutical regulatory affairs with specific expertise in Labeling, Advertising, and Promotion.

Manager - Regulatory Affairs & Quality Assurance - Pharmaceuticals - $140k – Cambridge, MA

Seeking Regulatory Affairs and Quality Assurance management experience with small molecule pharmaceuticals.

Senior Manager - Regulatory Affairs & Quality - Medical Device - $150k – Boston, MA

Seeking Regulatory Affairs and Quality Assurance management experience with Class II or III medical device products.

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We only recruit for the best organizations offering the most lucrative salaries, excellent benefits and career growth and advancement pathways.

Typical benefits include: High earning potential with high percentage bonus and uncapped commission structures; Fully company paid family medical, dental, vision, life & liability, and disability coverages; Generous PTO packages with 3 week vacation, personal and sick days; Long-term growth potential; Advancement and promotion opportunities; Profit sharing plans; 401(k) with match; Company provided association memberships and certification fees; All-encompassing travel reimbursement packages; Creative and forward thinking work environments; Collaborating with the best and brightest minds of today; Access to state of the art technology and much more.

Our clients will begin teleconferencing with candidates as soon as January 3rd, 2017. Don’t miss this chance to start the New Year with the career you’ve always wanted.

For details contact Branden F. Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:

1000025783_10007337@jobbank302.com

2+ years

Massachusetts

$115,000.00

$200,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000025783_10007337@jobbank302.com

http://dmc9.com/bfl/app.asp

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.

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