Title: Director, Regulatory Operations

Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.

Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales.  With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. This is a solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.

Currently looking for:   Director, Regulatory Operations

Job Description

The incumbent is responsible for providing supervision, management and leadership for Regulatory Operations in the planning, compilation, and publishing, of regulatory submissions.  The Director is also responsible to develop the expertise to assure the quality of the submissions, and adherence to regulatory standards and requirements for electronic and paper submissions.

The candidate works directly with all functional areas that author final reports, and sections of regulatory submissions.  The candidate will be the leading authority within the company to implement new guidance's and technologies, provide regulatory requirements for submission of documents to regulatory authorities (complexity of job, time required, etc.)  This person must be highly organized, skilled in effective communication and negotiation, able to manage a growing group, able to multitask, work well within the team setting, and prioritize work to meet critical timelines.

RESPONSIBILITIES

-Manage a team of regulatory documentation professionals

-Keep current on new guidance's relating to regulatory submission format and publishing -requirements.

-Understand electronic author, review, and archival systems. 

- Effectively communicate, engage and influence functional areas to implement new technologies

- Liaise with technical representatives to ensure integration of regulatory requirements in development work to provide appropriate documentation for filings. 

- Responsible for ensuring collection and quality of documentation in accordance with regulatory requirements.

- Lead, mentor and educate staff to build a learning and growth oriented culture

- Communicate and implement effective project submission plans

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE

- Must have experience in pharmaceutical development and have submissions experience

- Must have knowledge of EMEA guidance's, ICH guidelines, FDA guidance's for both clinical and commercial projects as they pertain to submission documentation.

- Must possess experience and understanding of IND, CTA, BLA and MAA, and the associated maintenance submissions (ex Annual Reports, amendments, variations, supplements)

- Must have demonstrated experience in CTD/eCTD requirements, and be familiar with global regulatory affairs workflow.

- Demonstrated skill in managing personnel

- Must have excellent communication skills and be able to establish and maintain relationships with various internal and external personnel.

- Demonstrated experience in compiling regulatory submissions including hyper linking and working with documentation systems

-  Commitment to excellence, possess both determination and attention to detail, have the ability to produce work to a very high standard

- Education requirements: Bachelor Degree with 10 years of relevant pharmaceutical industry experience.  Minimum of 8 years regulatory submissions experience (or equivalent) is required.  MS, or PhD.

To apply:

Please reply to:

Debbie Wilmer

Discovery Solutions LLC

443-402-1585

Debbie.wilmer@discoverysolutionsllc.com

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