The Director, Regulatory Affairs will develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders.
The Director, Regulatory Affairs also ensures that there is labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans and formulates regulatory labeling strategies for implementation of new and revised prescribing information.
Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues.
Advises and oversees internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes.
Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities.
Provide regulatory expertise to support Clinical Study teams.
Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs.
Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs.
Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings.
Works cross-functionally to develop and implement revised/new labeling strategies.
Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure a integrated approach to regulatory strategy.
Maintains global regulatory strategy documentation for assigned projects.
Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.
Mentors and trains junior regulatory staff.
Requires a BS degree or equivalent with a Master's degree or PhD preferred.
Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience.
Successful completion of an NDA and MAA application(s).
Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus.
Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process.
Working knowledge of eCTD submissions and supportive technologies.
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.