Manager, Regulatory Submissions at Dow Pharmaceutical Sciences, Inc. (California - San Francisco)

About Dow Pharmaceutical Sciences, Inc.:     compress
Dow Pharmaceutical Sciences, Inc. is a privately held, dynamic and growing independent contract drug development and consulting company, specializing in dermatological, opthalmic, and other topical products. We provide individual or integrated services to clients including formulation development, analytical and stability, clinical trial materials and regulatory and clinical affairs. Pharmaceutical development employees at Dow Pharmaceutical Sciences, Inc. are experienced, highly qualified team players, essential to the success of our company.

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About the Opportunity/Requirements:     compress
Employer Job Code: MgrRS_5_08_Rx

The Manager, Regulatory Submissions is responsible for preparing regulatory submissions, including IND’s, ANDA’s and NDA’s for dermatological products, and for providing counsel on submission strategies for internal and external clients/customers.
Primary Responsibilities:
• Prepares regulatory submissions
• Assist in the development of regulatory strategies and compliance
• Provide regulatory counsel for drug development programs internally and externally
• Maintain liaison with external clients, internal personnel and external consultants s
• Manage activities and budgets to achieve program objectives

Primary Functions:
• Act as the responsible person for continuing to lead the company toward fully electronic submissions.
• Act as the primary liaison with Informatics for identifying and procuring the appropriate hard and soft ware(s) to keep the company updated with the eCTD requirements.
• Act as the responsible person to maintain/update a training curriculum on the eCTD submission.
• Act as the responsible person to select vendor(s) to support eCTD readiness, implementation activities, and training process.
• Act as the primary person to interact with counterparts in CROs or development partners on the eCTD or any submission issue.
• Act as the primary liaison with the FDA to receive expert advice on the electronic submission.
• Oversee the Regulatory Submissions Group and ensure timely coordination and publishing of various regulatory submission documents.

Job Requirements:
• Excellent written and oral communication skills
• In depth understanding of CoreDossier/Insight or comparable software system
• Excellent organizational skills
• Strong project management skills
• Thorough understanding of new drug regulations
• Effective facilitator and negotiator
• Computer literate

Essential Functions:
• Must be able to create and manage eCTD submissions using CoreDossier
• Must be able to communicate effectively in a verbal and written form
• Must be able to work proficiently with computers and general office equipment

Required Education/Experience/Training:
• Bachelors degree in science/health field (Pharmacy, Chemistry, Microbiology, or Biology);
• Minimum 3 years of experience in regulatory submissions;
• Minimum 2 years experience in the area of electronic submissions in the pharmaceutical industry or equivalent;
• Knowledge and experience with CoreDossier is essential;
• Expert knowledge of the ICH and FDA eCTD specifications;
• Working knowledge of EU eCTD specifications a plus;
• At least one year of experience in leading a successful electronic submission of IND, or marketing application;
• Superb experience with the preparation of INDs, NDAs.

 

Additional Information:
Dow Pharmaceutical Sciences, Inc. is located in Petaluma, CA, 40 miles north of the San Francisco Bary area. Please visit our website at www.dowpharmsci.com for more information.
 

Application Instructions:
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