Sr. Manager I-III, Regulatory Affairs Ambit Biosciences
THIS JOB HAS EXPIRED Description:
The Sr. Manager of Regulatory Affairs will work with cross functional teams to establish and implement regulatory strategies for Ambit products, assuring the regulatory viability of drugs in development, while forecasting the regulatory environment to identify changes that may impact Ambit. The candidate will work with the teams to establish collaborative interactions and negotiations between Ambit and various regulatory authorities and agencies. The candidate will also maintain an ongoing dialogue with the Ex-US Regulatory Agencies and CRO?s, oversee regulatory documentation, filings and the registration process, and provide regulatory strategic input into development teams. They will also be responsible for the management/compilation and filing of INDs, annual reports, adverse event filings, maintenance of documentation (archiving), and other activities required to conduct preclinical studies and clinical trials.
Essential Job Functions:
?Work with the Sr. Dir. RA/QA and with the cross functional teams to set regulatory strategy and timelines as well as handle the interface with global regulatory agencies in support of the strategic development vision of Ambit
?Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs
?Lead regulatory strategy development and implementation, and advise on strategies necessary to optimize drug development programs and lifecycle management
?Author regulatory development plans and timelines for global clinical trial applications and market registrations (INDs/IMPDs/CTAs, NDAs/MAAs)
?Identify regulatory risks for investigational and to-be-marketed drugs and develop strategies to minimize those risks
?Build and maintain collaborative relationships with regulatory agencies, identifying issues and solutions, and negotiating complex regulatory strategies, and plans
?Review new/ revised labeling (labels, bulk labels, inserts, cartons, etc.) and assure compliance with current regulations
EDUCATION:Bachelor?s degree plus training in regulatory affairs. An advanced degree, MS, or PhD in Life Science or PharmD is preferred.
EXPERIENCE:Minimum five (5) years pharmaceutical or biotech industry experience in regulatory affairs.
Experience within oncology and/or inflammatory diseases preferred.
COMPETENCIES AND SKILLS:?Able to prepare and review regulatory submissions including INDs/IMPDs and MMA?s and NDAs or equivalent. IDE/PMA experience a plus
?Experience with reviewing and resolving CMC regulatory issues for small molecules
?Ability to interact with multiple regulatory agencies
?Experience in Pre-IND Meeting preparations, IND applications, and IND maintenance (such as Annual Reports, Safety Reports and IND Amendments). Preparation of submissions to other regulatory agencies desirable. Prior training and experience with eCTD-compliant submissions, including electronic INDs, NDAs, MAA?s highly desirable
?Familiarity with Global regulatory requirements, specifically EU. Must have experience with EU Clinical Trial Applications
?Collaborative team player that can establish and maintain effective working relationships with other departments, the FDA, EU rapporteurs, TPD, PMDA, and outside vendors
?Excellent interpersonal skills with knowledge of negotiations, influencing and conflict management to assure effective interactions within and across departments
?Ability to contribute regulatory expertise and advice across multiple areas
?Experience with Ex-US Corporate Partnering and/or comarketing of drug products
?Results oriented, sense of urgency, sound judgment and attention to details
?Must be flexible and able to effectively manage multiple competing priorities
?An innovative, ?outside-the-box? thinker and leader, must have sound organizational skills
?Confidence to work in a small company setting
TECHNICAL KNOWLEDGE:Equipment: PC, scanners, voice mail, and email systems, and other common machines. Must have the ability to be trained on new equipment.
Software Knowledge:Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe.
ENVIRONMENTAL CONDITIONS:Physical Activities: While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory Activities, if applicable: Experience with biological, animal, and chemical laboratory environments required. Environmental health and safety processes also apply.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED