Sr. Manager, Regulatory Affairs

The position of Senior Regulatory Manager is responsible for the preparation and management of regulatory submissions, and will contribute as a liaison with internal staff, business partners, and regulatory authorities to identify and manage initiatives to improve department capabilities. The Senior Manager, Regulatory Affairs will conduct critical reviews of key technical documents aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents, and ease of review. This position provides critical support to the Director, Regulatory Affairs in the facilitation of regulatory functions as defined in department SOPs and standards. This position provides the incumbent with a broad exposure to both regulatory affairs and business operations for the pharmaceutical industry. Persons in this position must be highly organized, attentive to detail, and disciplined. He/she must demonstrate a consistent ability to work under pressure and meet all deadlines.

Duties and Responsibilities

For all assigned products:

-Represent Regulatory Affairs as a member of Forest Project Teams

-Provide regulatory strategy to teams and management towards the filing and approval of INDs and NDAs

-Actively monitor and advise applicable team members and product managers of upcoming regulatory affairs deadlines and other critical dates (e.g. patent expiration)

-Proactively solicit regulatory submittals from other company departments including: preclinical, clin/pharm, clinical development, commercial (marketing), and manufacturing.

-Assure the proper management, retention, and version control of all applicable Regulatory Affairs and product documentation.

-Coordinate activities for paper-based and electronic submissions with applicable regulatory agencies. Prepare submission packages and on approval, submit materials to applicable agencies.

-Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs.

-Identify areas for improvement within daily functions, internal procedures, and regulatory agency interaction.

-Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions.

-Prepare applicable management reports related to assigned products.

-Maintain a high level of expertise through reading and participation at professional seminars,workshops.

-Exercises outstanding judgment in all areas of responsibility.

Requirements

Education:

-Bachelors Degree in life sciences required.

-Advanced Science Degree or equivalent experience preferred.

Experience:

-Regulatory, professional with a minimum of 3 - 5 years of Pharma and regulatory affairs experience, including IND and NDA filings.

Basic understanding of the following functional areas (within the context of regulatory affairs): - Quality Assurance - Labeling - Promotion - Drug Safety - Licencing - CMC

Licensure/Credentials:

RAC certification a plus

Knowledge, Skills, and Abilities

Technical Qualifications: -Knowledge of all relevant pharma regulatory procedures and reporting requirements -Experience with document management of INDs, IND Amendments, FDA Briefing Packages, and NDAs. -Experience with CTD and e-NDA/e-CTD preparation preferred.

Strong technical background including proficiency in Windows, Microsoft Office Suite, and Documentum

General Qualifications: -Superior communication skills in a team-based environment -Energetic, self-motivated, organized individual who is accustomed to working in deadline-focused, high-pressure entrepreneurial environment. -Ability to manage multiple simultaneous products/projects. -Proficiency in both written and verbal communications and presentations -Strategic, analytical thinker with strong business acumen -Proactive, disciplined, organized, and detail-oriented. -Demonstrates consistent logic, rationality, and objectivity when identifying significant problems and opportunities. -Creative problem solver with the ability to establish systems and define standard practices. -Displays high level of integrity by remaining consistent in terms of what he/she says and does in terms of behavior toward others. -Willing team player capable of working collaboratively with colleagues in their department and in all functions

Posting Date: 10.21.09

Forest Laboratories, Inc. is an equal opportunity employer.

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Please refer to job code 98105 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Jersey City, NJ
County:	Hudson County
ZIP Code:	07097
Pay Rate:	Open
Job Terms:	full time
Company:	Forest Laboratories, Inc.
Phone:	email only please
Fax:	email only please