Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs
The Associate Director is responsible for developing and implementing innovative global regulatory strategies in support of various departments, projects, and sub-teams. In addition, the Associate Director represents the regulatory department with contractors and corporate partners, and may serve as the regulatory contact with relevant regulatory authorities, as determined by senior management. This role is responsible for the implementation of assigned projects and services, with optimal efficiency, through effective leadership, as well as the work performance and technical development of their staff.
Advance those of the Manager/Lead Technical Specialist to include the following:
- Directs the planning and coordination of clear and effective of regulatory submissions
- Ensures the alignment of regulatory strategy with department and corporate objectives, for assigned projects
- Performs regulatory review of promotional materials, data presentations and other external communications
- Prepares and delivers effective presentations for internal and external audiences
- Ensures electronic and paper submissions adhere to current regulatory submission practice
- Participates in the design, development and implementation of department strategies, providing recommendations in their area of expertise
- Leads cross-functional teams on assigned projects to successful conclusions
- Communicates clearly and effectively with regulatory authorities, where relevant
- Regularly interacts with subordinates, outside contacts and functional peer groups at various management levels
- Builds and maintains excellent relationships with contractors and corporate partners
- May supervise other regulatory staff
- Performs other duties as assigned
Managerial and Communicative Skills:
- More advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development, labeling and promotion
- Ability to communicate with all levels within the company and can act as liaison / representative both internally and externally
- Exhibits project management skills necessary to perform complex tasks independently and work on multiple projects simultaneously
- Actively pursues innovation and excellence and is able to motivate others to pursue these values
- Possesses a distinguished record of enabling the goals of regulatory projects in support of corporate and department goals
- Applies an in-depth understanding of regulations and guidelines beyond their own specialty area
- Recognized internally as an expert resource in their area of specialty
Master’s degree; and a minimum of 8 years regulatory experience in the pharmaceutical industry
- Bachelor’s degree and a minimum of 12 years regulatory experience in the pharmaceutical industry
- Success leading a drug filing process from pre-IND through NDA/BLA registration.
- Thorough knowledge of the drug development process and laws and regulations affecting the pharmaceutical industry in the U.S.
- Recognized expert in regulations, guidelines and precedents related to pharmaceutical development for small molecules or biologics.
- Experience in managing staff performance and career development.
- PHD or Medical Degree and 8+ year of Pharmaceutical or Biotech experience
- 2+ year of experience with direct interaction with the FDA
- 2+ year management experience
- Compelling interpersonal, verbal, written and presentation skills in communication with internal and external customers.
- Proven ability to lead organizational change and innovation
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist.
For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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