MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Regulatory Affairs Director will be responsible for post-marketing regulatory activities, including advertising and promotional material review, maintenance of product information labeling, and the compilation and submission of required post-marketing regulatory reports. Also responsible for directing all regulatory activities in preparation for launch and commercialization, in coordination with other functional areas. This individual will provide regulatory leadership to cross-functional teams responsible for commercialization and ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
- Manages regulatory aspects of the review and approval process for product advertising and promotional materials, attend and provide content input to the product review committee meetings, maintain compliance of promotional materials with the governing FDA regulations, and ensure submission of promotional materials to FDA in a timely fashion
- Manages the regulatory aspects of the review and approval of product information labeling, and maintain the compliance of labeling with regulatory authority requirements and with internal SOPs
- Ensures regulatory activities to support marketed products meet established timelines and are aligned with MacroGenics’ short and long-term business strategies and goals
- Serves as point of contact with regulatory authorities, contractors and corporate partners, where relevant, for specific projects
- Represents Regulatory Affairs on cross-functional teams, including cross-functional teams responsible for commercialization. Provides expert opinions, advises staff on available strategies and/or methodologies which reflect the most up-to-date regulatory and compliance standards
- Interprets, identifies, recommends, and advises MacroGenics teams and Company on regulatory guidelines and risk matters and is accountable for the development and implementation of plans to address regulatory and/or product issues
- Contributes to the continuous improvement of existing department processes and strategies, providing recommendations in their area of expertise
- Assists on other MacroGenics project-related activities, as necessary
Education & Other Credentials
Bachelor’s degree in the life sciences or a field of study that will benefit the position
- Minimum of 10 years in regulatory affairs
- Demonstrated successful experience in applying current and evolving regulatory requirements to post-marketing activities, especially in advertising and promotional material review
Knowledge, Skills and Abilities
- Strong scientific knowledge and regulatory experience applicable to the role.
- Ability to deal with in-depth technical information from a variety of disciplines and a proven, successful track record of establishing and maintaining a high degree of scientific credibility with regulatory authorities.
- In-depth technical and regulatory knowledge of the regulatory requirements to maintain compliance with advertising and promotional materials and with product information labeling.
- A proven track record in interactions with regulatory authorities, as applicable to the responsibility of the specific role.
- Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders.
- Strong analytical and problem-solving skills
- Proven leadership and negotiation skills