Director of Regulatory Affairs and Operations

Our client is a biopharmaceutical company focused on developing innovative, inhaled pharmaceuticals for the site-specific treatment of serious lung diseases such as pulmonary infections in cystic fibrosis patients and cancers affecting the lung. They are committed to significantly improving the quality of life and healthcare of patients suffering from these life-threatening diseases. Their operating principles are centered on teamwork, openness, and mutual respect, diversity of opinion, trust, accountability and innovative science. In addition to an outstanding work environment our client provides a comprehensive and competitive total compensation package for employees and their families.  This package includes: Competitive Salary, Annual Performance Bonus, Opportunity Stock Options, Health Insurance, Dental Insurance, Short-Term/Long-Term Disability and Life Insurance, Flexible Spending Accounts for Dependent and Medical Care, 401K Plan, Paid Vacations and Paid Holidays, Business Casual Environment, Company Sponsored Outings, and Family Events. Come make a difference with a world-class team! Director, Regulatory Affairs and Operations Working in a team environment, the Director of Regulatory Affairs and Operations will be responsible for planning and coordinating regulatory submissions necessary to support clinical trials and product registration. This position will represent the company with domestic and international regulatory authorities and provide regulatory support for various departments, projects, and teams/committees. Responsibilities Create and execute regulatory development plans and manage timelines to achieve the stated goals Interface directly with governmental personnel, including scientific reviewers, administrative support and management to facilitate the review and approval of regulatory applications Work closely within the department and across the project team to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance Ensure clear communication of project activities and progress in a timely manner Coordinate the preparation and submission of required documents to regulatory agencies with an emphasis on pre-IND, IND and Phase II submissions Ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements Make certain that appropriate documentation is maintained to record regulatory decisions for the projects Develop and maintain strong and effective relations with internal/external personnel Responsible for interaction with the clinical research area Filing necessary applications and handling all government interactions pertaining to the Regulations process and products requiring government approval Familiar with a variety of field concepts, practices and procedures Assist in developing procedures to ensure regulatory compliance Development and implement innovative regulatory strategies for development projects Manage the planning and coordination of productive and effective regulatory submissions and regulatory agency meetings Monitor and analyze regulatory agency activities and advise senior management on appropriate action Provide leadership on teams and committees in all areas of regulatory affairs and product development Build and maintain excellent relationships with regulatory authorities Serve as responsible contact with regulatory authorities and corporate partners Manage regulatory staff; including setting goals and priorities consistent with department and corporate goals Other duties as assignedKnowledge and Skills Bachelor’s Degree in chemistry, biology or life sciences field PhD, Pharm.D, or MD preferred 7+ years experience in regulatory affairs providing regulatory guidance in the development of drugs and/or post-marketing support of drugs Working knowledge of FDA organization, regulations and guidance documents Knowledge of regulations pertaining to global regulatory agencies Experience and knowledge in preparation of INDs, NDAs, MFs, and supportive amendments of supplements Must have knowledge of GMPs regulations as well an understanding of the pharmaceutical product life cycle Demonstrated ability to manage multiple assignments, appropriately identify and resolve regulatory issues, and communicate as needed to management Demonstrated ability to work independently and manage multiple projects within cross-functional teams Strong negotiation, communication and interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff Demonstrates expert knowledge of regulations, guidelines and precedents related to drug product development, labeling and promotion Proven track record of successful interaction with regulatory authorities and in preparation of Demonstrated ability to lead organizational change and innovation Proven ability to impact and influence the decisions of a team, decision making committees MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: NJ 08810 JOB CATEGORY: Legal TYPE: Full Time, Employee JOB REFCODE: EB-4714708215 COMPANY: Dennis Partners