Executive Director – Regulatory Compliance

Our client is a fully integrated, research-based pharmaceutical company.  They are one of a very few companies, aside from multinational pharmaceutical companies, that has demonstrated the ability to advance compounds from discovery of their own proprietary compounds, through all the elements of development, to full commercialization of drugs for therapies prescribed principally by primary care physicians. 

 

Their focus has been to serve unmet needs in both the respiratory and central nervous system therapeutics areas.  They currently have several US FDA-approved drugs as well as a robust pipeline of early to late-stage assets that are advancing through the drug development process. 

 

The company?s research and development and marketing efforts are now of a scale that positions them as a potential partner of choice for in-licensing late-stage opportunities from regionally focused European or Japanese pharmaceutical companies that do not have their own U.S. sales and marketing infrastructure.  In addition, their development capabilities position them as an attractive marketing partner to U.S. biotechnology companies who seek alternative to multinational pharmaceutical companies.

 

RESPONSIBILITIES:

Provides strategic and sensor management oversight for regulatory compliance activities, principally the CMC and marketed products support functions, and in this capacity serves as a key executive on Quality System committees. Key responsibilities are:

? Directs the activities of the Technical Regulatory Affairs staff and preparation and submission of CMC sections of regulatory dossiers for marketing applications, post-approval regulatory files (supplemental NDAs, Annual Reports, variations etc.) for approved products. Assures that submissions comply with FDA requirements.

? Interacts directly with regulatory agencies and personnel on CMC matters, including BOA CMC reviewers, to facilitate Agency assessment of CMC sections of Company Confidential IND and NDA applications. Organizes and manages meetings (such as EOP-2, Pre-NDA meetings) with FDA CMC review personnel to obtain commitments and agreements enabling rapid and compliant development of Company Confidential new drug development programs.

? Interacts directly with regulatory agencies to resolve CMC related questions and facilitates approval of market applications, post-approval product, manufacturing, and labeling changes.

? Provides CMC regulatory strategy input to senior management in cross-functional groups (e.g., Program Management, Chemistry & Pharmaceutical Sciences, Commercial Technical Operations, and Corporate Quality Compliance). Provides CMC regulatory assessment of post-approval changes; devises CMC regulatory strategies for expedited approval and implementation of these changes. Provides CMC regulatory input in the assessment of new product acquisition and product out-licensing candidates. Coordinates with contract manufacturers, Company Confidential Outsourcing Groups and Quality Assurance to effect accurate technical sections in approved applications to assure compliance with regulations and submission commitments.

? Devises CMC regulatory strategies for rapid and cost-effective product development and registration of new product candidates. Provides CMC regulatory input to development teams (Chemistry & Pharmaceutical Science/Quality/CTO) including timing, and logistics and develops CMC regulatory submission strategies in agreement with defined project development objectives and in compliance with FDA regulations.

? Serves as a core member of the Promotional Materials Review Committees. Reviews, helps develop and approves advertising, promotional materials, sales training and other materials involving communications about marketed products. Provides guidance in the development of compliant sales training, advertising and detail literature. Advises Sales, Marketing and other departments on regulatory issues arid impacts of promotional activities. Supervises full time and contractor staff involved in materials review and approval, and provides guidance to RA on these matters.

? Interacts directly with regulatory agencies and personnel on advertising and promotion matters, including DDMAC staff, to facilitate Agency assessment of draft advertising and promotional materials, and to resolve issues arising from Agency review of these materials.

? Serves as a core member of the Scientific Materials Committee. Reviews, helps develop and approves presentations and materials to be used by medical liaisons and other scientific staff. Advises Medical Liaison and Medical Communications groups regarding regulatory issues and impacts of these activities.

? Serves as a core member of the Publications Planning Team. Reviews, helps develop and approves publications and abstracts, and advises on regulated uses of these materials. Coordinates these activities with R&D submission and labeling development strategies and with FDA labeling negotiations.

? Serves as core member of the Medical Information Working Group. Reviews, helps develop and approves standardized communications to be issued in response to spontaneous inquiries front healthcare professionals and consumers.

? Develops regulatory risk assessment profiles for all regulated aspects of new drug development, post marketing support and Quality/GMP compliance issues. Communicates risk assessment to senior management.

? Monitors the US and international regulatory environments, and provides senior management with assessments of the impact of new and changing CMC and advertising/promotion regulations on the Company?s programs.

? Develops and implements training programs for direct reports and other functional groups to assure awareness of all CMC and DDMAC requirements so as to facilitate compliance with all current regulations.

? Interacts with vendors to coordinate submission of Drug Master Files (DMFs) and resolution of CMC deficiencies

? Prepares group/departmental operating policies and procedures

 

ESSENTIAL FUNCTIONS REQUIRED FOR JOB

Functions as the key person to

? Manage Regulatory Compliance staff

? Directly interact with regulatory authorities to expedite developmental and post-approval CMC activities, as well as advertising and promotional material submissions.

? Provide regulatory compliance leadership, consultation and guidance to project teams, The Commercial Division, R&D and Quality groups

 

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED 

Education

? Ph.D./MS/BS in related science field (e.g. Biology, Chemistry, Pharmacy); MBA desirable

? Expert in current regulatory guidelines pertaining to drug marketing and development, with particular emphasis on CMC and DDMAC matters. Strong knowledge of and experience in regulatory liaison matters is a plus.

 

Experience/Skills

? Minimum of 10-15 years of experience in regulatory affairs and/or compliance, including some experience at a senior level

? Strong leadership abilities and excellent communication/interpersonal skills; must exhibit ability to influence decision making and effect implementation of regulatory strategies and considerations in alignment with organization goals.

? Prior people/project management experience, with a demonstrated capability to lead and motivate staff.

? Experience in effective communication with FDA and other regulatory agencies.

? Thorough understanding of GMP and Quality compliance issues.

 

Complexity

? Ability to handle multiple projects

 

Mental/Physical Requirements

? Fast paced office environment handling multiple demands.

? Must be able to exercise appropriate judgment as necessary.

? Requires a high level of initiative and independence.

? Requires excellent written and oral communication skills.

? Requires ability to use a personal computer for extended periods of time.

 

Additional Requirements

Work hours may include meetings scheduled outside of normal working hours. Demands during peak times may require work hours outside of normal working hours. Occasional travel may be required.