Director, Regulatory Affairs Liaison

 Director, Regulatory Affairs Liaison

 

Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) is focused on becoming a global leader in the research, development and commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections.  Founded in 1992, Cubist is headquartered in Lexington, MA.  For more information about the company, please visit our website at www.cubist.com.

 DESCRIPTION

 

The Director of Regulatory Affairs Liaison will have a direct role in drafting, reviewing and administering regulatory strategy and policy throughout the drug development process.  Expectations will be to effectively liaise, negotiate and partner with all global regulatory authorities. The incumbent will ensure that the quality and content of submissions will lead to successful and timely approval of regulatory applications.

 

Responsibilities:

 

?  Liaison with global regulatory authorities

?  Lead regulatory strategy development and implementation

?  Lead product labeling content development

?  Author regulatory development plans for global registrations

?  Collaborate with partners to ensure successful global registration planning and implementation

?  Provide strategic regulatory representation on project teams

?  Communicate regulatory policy to internal customers and provide clarity on regulatory expectations, when needed

?  Review/approve all regulatory submissions

?  Review final corporate drug development reports and regulatory submission documents for approval

?  Advise on strategies necessary to optimize drug development programs

 

Education & Experience:

 

?  Bachelor?s degree minimum

?  An advanced degree in the physical/life/medical sciences preferred

?  8+ years of relevant experience in the development of drugs or biologics

 

 

Benefits:

 

Our outstanding benefits package includes: 100% vesting in our 401K plan, choice of HMO/PPO medical plan, employee stock purchase program, dental, life and disability insurance, tuition reimbursement, flexible spending accounts and 3 weeks vacation. In addition, we have unique extras such as: on-site massage therapy, 11 holidays, 4 of which are floating, EAP benefit focusing on work life balance issues and frequent celebratory parties!

 

 

Search Firm Representatives:

 

Please Read Carefully.

Cubist is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Cubist via email, the Internet or directly to hiring managers at Cubist in any form without a valid written search agreement in place for that position will be deemed the sole property of Cubist, and no fee will be paid in the event the candidate is hired by Cubist as a result of the referral or through other means. Note: Any search agreement entered into prior with Cubist to January 2006 is hereinafter void.

Search firms are essential to the recruitment and staffing efforts at Cubist and we value the partnerships we have built with our preferred vendors. For this reason, Cubist has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Staffing Consultant at Cubist in place for the specific position in order for a fee to be paid for any candidate referrals.