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DIRECTOR OF REGULATORY AFFAIRS

Director of Regulatory Affairs

Would you like to work for an innovative company?
If so, come join our team!

Job Overview:

This role requires knowledge and experience of the pharmaceutical regulatory environment, both with the FDA and internationally. The position requires strong regulatory and CMC competency in both operational and strategic areas to ensure that sound regulatory and compliance practices are fully integrated in all nonclinical, CMC, clinical development and post-marketing activities.

The person to fit the role will also be expected to continue to build an organizational framework that improves the probability of success for all regulatory activities through enhanced teamwork and collaboration and to design and incorporate the company’s global regulatory strategies into development plans. Pursue positive communications and rigorous interaction with the GDA and other international regulatory agencies and ensure development and manufacturing activities meet all relevant requirements and guidelines. Additional responsibilities may include assisting the primary evaluation of potential in-license products, as needed.

Job Responsibilities:

• Directing regulatory operations related to product development, approval and commercialization.
• Defining strategies for meeting and maintaining compliance.
• Representing the company with domestic / international regulatory authorities, etc.
• Providing regulatory support for various departments, projects, teams / committees.
• Performing critical review of submissions to ensure completeness, accuracy, compliance with agency regulations, appropriate scientific rationale and strategic impact.
• Identify / assess regulatory risks associated with product development and strategies to mitigate risk.
• Monitor / analyze regulatory activities relevant to the company.
• Manage / execute publishing activities including submissions / related reports for new and existing product (s).
• Main interface with project teams providing guidance and communication of submissions, processes and standards, in addition to planning and negotiating timelines.
• Work with internal / external colleagues to ensure resources are available for timely delivery of submissions.
• Proactively identify / assist in resolution of priority conflicts and capacity constraints to ensure submission milestones / deadlines are managed successfully to meet regulatory commitments and company objectives.
• Oversee activities for electronic submissions’ development / filing and track metrics associated with submission publishing and rework and manage central records / files and systems.

Excellent Salary:

Benefits include:
401k, Stock Options, Medical / Dental Insurance, Vacation and Sick Time.

Job Requirements:

• Minimum of Bachelor’s degree plus 10 years regulatory experience and expertise in the areas of GCP’s, cGMPs and GLPs.
• Publishing experience in domestic and international regulatory submissions that involve planning and compilation to include both electronic and paper submissions utilizing current csoftware and tools.
• Experienced and self-motivated with a record of achievement in past initiatives submitting IND(s), NDA(s), CTA(s).
• Domestic and international regulatory experience dealing with regulators in various governmental agencies and have developed and maintained excellent working relationships with regulatory authorities.
• Effective problem solving and strong understanding of regulatory affairs.
• Excellent written and verbal skills and the ability to communicate clearly, concisely and effectively and represent the department in project teams, committee and external meetings.
• Strong interpersonal skills and the ability to prioritize multiple tasks and effective in managing budgetary and fiscal responsibilities.
• History of developing a culture of teamwork, collaboration and communication, especially in small startup environment.

For immediate consideration, please forward a copy of your current resume to info@profrecruiters.com referencing job # or a link to this job.

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