Celgene Dir, Reg Affairs in San Diego, California
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The incumbent will plan, implement, and manage assigned regulatory projects and submissions for investigational and marketed drug products sponsored by Receptos. A primary responsibility is collaborating in developing and carrying out regulatory strategies aimed at the most efficient regulatory approvals for Receptos development products. This involves collaboration in planning clinical trial strategy, including IND submissions, and managing the preparation and submission of NDAs and BLAs among other required filings. Further, the Director, Regulatory Affairs is responsible for assuring that Receptos is compliant with federal and state legislation, regulations, and guidance with regard to drug development, clinical and preclinical research, drug marketing and sales, and post marketing reporting for all drug products marketed by Receptos. The Director, Regulatory Affairs is responsible for assuring that all advertising and promotional labeling for Receptos products complies with federal regulations.
Responsibilities and Duties:
Direct the development of regulatory strategies for Receptos products in accordance with all current applicable U.S. and local requirements.
Represent Receptos and act as a company spokesperson in communications with drug regulatory agencies.
Ensure timely and accurate regulatory submissions in compliance with all applicable regulatory requirements, and in alignment with corporate goals.
Direct and assist internal staff, contractors and consultants as required, to ensure compliance of Receptos drug development activities with all U.S. and international cGMP, GLP, and GCP requirements.
Provide management with regulatory due diligence advice for potential new product opportunities.
Participate as Receptos Project Team(s) Leader for assigned projects; and serve as Regulatory advisor for other product development project(s).
Grow corporate, project and industry knowledge. Analyze and communicate current Regulatory issues and information to senior management and other departmental personnel.
Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Other responsibilities as assigned.
B.S. with science major. Advanced degree preferred.
At least 10 years U.S. regulatory experience with drugs and/or biologics products.
Thorough knowledge of the drug development process and global submission process
Previous experience directing and coordinating FDA interactions.
Previous management experience in the pharmaceutical industry.
Previous experience providing leadership and regulatory expertise in project team development environment.
Computer literacy, e.g. Microsoft Word, Excel.
Excellent interpersonal skills.
Excellent writing and editorial skills.
Effective communication skills.
Effective team participation skills.
Ability to think strategically.
Experience in drafting and coordinating submissions of U.S. regulatory documents, such as INDs, IND annual reports and IND safety reports.
Willingness to take on job assignments outside of regulatory submissions such as assisting in compliance efforts, including GMP, GLP, and GCP compliance assessments and audits, communicating strategies and assisting outside consultants and contractors with Receptos development efforts.
International as well as U.S. pharmaceutical experience.
MS or advanced degree in health or science-related field.
Project Team leadership experience.
Experience with gastrointestinal drug products.
Experience with FDA communications.
Experience with electronic filings.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.