Employment Opportunities:

Director, Regulatory Affairs - Bannockburn location

The Director or Senior Director, Regulatory Affairs is a tactical and leadership position that reports to the Vice President of Clinical and Regulatory Affairs and is responsible for devising and implementing regulatory strategies for late stage development and post-approval products.  The position responsibilities also include serving as a secondary liaison with regulatory agencies regarding quality systems and compliance policies and will be located in the new Chicago office.  The position will be located in the new Chicago office and is expected to evolve into a supervisory position as the company advances development and commercialization of its leading compounds.  Thus, the ideal candidate would have management and mentoring experience and would be expected to inspire and motivate, and to serve as a role model for reports and colleagues.

Key Responsibilities:

• Contribute in proactively formulating global regulatory strategies that interpret and reflect regulatory and corporate guidelines
• Plan, manage and implement regulatory programs into multidisciplinary project teams for all products from late-stage development through commercialization
• Represent Cytochroma at FDA, DDMAC and other regulatory agencies
• Initiate and respond to regulatory agency contacts (e.g. telephone, email, written, meetings) to negotiate successfully with regulatory agencies to achieve business objectives
• Responsible and accountable for regulatory review of promotional materials and for ensuring regulatory compliance of product brand
• Review global product promotional materials and press releases
• Ensure that all documents to be submitted to regulatory agencies are complete, scientifically accurate, well-organized and of high quality in such a way as to facilitate review
• Assist with the technical transition from pre-approval research to post-approval commercial phase
• Assure compliance with all agency regulated late-stage development and post-approval activities including timely and accurate submissions of annual reports and supplemental filings.
• Assure that all regulatory and quality related activities and functions are current, are implemented fully and are compliant with defined standards, and that company personnel are trained appropriately
• Build and maintain good business and working relationships with internal and external groups
• Communicate to senior management of regulatory status and risks related to products and compliance
• Work with internal departments and external CROs and CMOs to assure timely and cGXP compliant disposition of products
• Communicate openly and effectively, working to develop team-based approach and to lead and to motivate regulatory and compliance activities
• Interface directly with regulatory agencies to host regulatory inspections
• Provide guidance on system validations tasks and product release
• Assist senior management to formulate and to establish company policies and operating procedures (SOPs)
• Participate in activities related to potential in-licensing and out-licensing of products

Requirements:

• BSc in biological or chemical sciences; advanced degree is preferred
• 5-10 years pharmaceutical industry regulatory experience including regulatory submissions to support product approvals and renewals, and post-marketing strategies and commercial awareness
• At least 2 years people and project management experience with strong interpersonal skills and proficiency in verbal and presentation capabilities
• Ability to work independently and as a functional leader and participant in teams
• Knowledge of Quality Management Systems would be a plus
• Approximately 20% travel within the United States and International

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.