Sr. Manager/ Associate Director Regulatory Affairs (239-419)
ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.
Supports regulatory objectives, advice, and strategy in alignment with department and corporate goals. Plans and manages regulatory document preparation for regulatory submissions. Keeps abreast of evolving regulatory procedures and practices.
Duties and Responsibilities
The Manager of Regulatory Affairs will be responsible for ensuring that ARIAD Pharmaceuticals is executing regulatory strategies globally and supporting interactions with regulatory authorities appropriately.
- Support the development of regulatory strategies and plans to advance ARIAD products through the regulatory review and approval process globally.
- Communicate effectively with teams and senior managers.
- Review and interpret regulatory correspondences
- Interact proactively with other ARIAD functions, contract research organizations, partner companies, and health authorities
- Plan and support the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle
- Review and provide regulatory advice for documents prepared by other departments.
- Work effectively with regulatory colleagues specializing in CMC and Operations to continuously improve regulatory systems, teamwork, and efficiency
- Contribute to improvements in department operating procedures
- Remain current with evolving regulatory procedures and practices, and provide guidance to ARIAD project teams
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.
BS degree, preferably in a scientific discipline with a minimum of 5 years pharmaceutical / biotechnology experience and a minimum of 3 years regulatory experience. Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability. Familiarity working with electronic document management and submission platforms is desired. Experience in oncology, with successful NDA submissions, or post-marketing experience is preferred. Strong commitment to business ethics. Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.
Submitting a resume online at a job site could cause valuable screening information to be missed.
Click here to apply:
ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.