Director, Regulatory Strategy - North America/Latin America

Company:	Covance Company Profile \| Current Opportunities (3)
Job Location(s):	Emeryville
Employment Term:	Regular
Employment Type	Full Time
Start Date:	As soon as possible
Starting Salary Range:	Not Provided
Required Education:	Doctorate
Required Experience:	Open
Related Categories:	Government - Policy/Legal

Position Description

Business Title	Director, Regulatory Strategy - North America/Latin America
Requisition ID	21331BR
Job Category	Regulatory Affairs
Locations	USA - Emeryville, CA USA - Chandler, AZ USA - Conshohocken, PA USA - Dallas, TX USA - Daytona Beach, FL USA - Evansville, IN USA - Gaithersburg, MD USA - Indianapolis, IN USA - Madison, WI USA - Nashville, TN USA - North Central USA - Northwest USA - Phoenix, AZ USA - Princeton, NJ USA - San Diego, CA USA - Scottsdale, AZ USA - Seattle, WA USA - South Central USA - Southeast USA - Midwest USA - Nationwide USA - Northeast USA - South USA - West
Shift	1
Job Posting	Imagine working in one of the most exciting and professionally satisfying industries anywhere. Imagine being involved in cutting-edge projects on a daily basis. At Covance, your imagination, your dedication, and your drive to find solutions to challenging projects begin on your very first day. Covance is one of the world’s largest and most respected contract research organizations. Our clients are a Who’s Who of the pharmaceutical and biotechnology industry. If you’re looking for a diverse and stimulating work environment, you’ll find it at Covance. The Director, Regulatory Policy and Strategy, North America/Latin America position provides regulatory support for North America (US & Canada) & Latin America region, including coverage Mexico, Columbia, Brazil, Chile , Argentina, Venezuela to the Global Regulatory team in one or more therapeutic areas for medicinal/ biologic products. The position provides regulatory support for development of drugs, biologics, food and nutritional supplements, medical devices, cosmetic and OTC products. The position is responsible for working with the regional operating business unit functions and global regulatory teams assigned to support our Clinical Development Services (CDS) programs to ensure compliance with regional regulations and interpretations. The Director, Regulatory Policy and Strategy position keeps up-to-date on regional/ local regulatory environment and advises the global regulatory team and project team on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the regulatory strategy, global submissions plan or other team deliverables. The Director, Regulatory Policy and Strategy advises the CDS Global Regulatory Team, and project team on required documents and processes to support Health Authority contacts and submissions. The position identifies opportunities and timing for meetings/ submissions with Ministério de Sade (Brazil), Secretiéra de Sulud (Mexico), ANMAT (Argentina), Ministeria de Salud de Chile (Chile), Ministeria de Salud de Columbia. As key member of CDS Global Regulatory Team(s), this position will interact with CDS personnel, including representation of Clinical Pharmacology, Early Clinical Development (Proof of Concept), Phase II/III Clinical Development and Peri-Approval business units. This position will work with CDS functional areas to implement local/regional regulatory strategy in a manner consistent with global regulatory strategic plan. The Director, Regulatory Policy and Strategy will act, as assigned, as designated Regulatory Liaison to local health authorities in the region. The Director, Regulatory Policy and Strategy leads the coordination and preparation activities for designated meetings and submissions for the regions, along with global regulatory, project development team and regional/ local regulatory submissions staff. The position contributes to the preparation and review of regional, and local documents for submission. Manages follow-up of regulatory dossiers after submission and manages responses to questions asked by Health Authorities for the region. The position tracks progress for assigned projects and generates reports for management as required. Travel: 10-20% domestic/international travel required.
Education/Qualifications	Advanced degree (PharmD, MD, PhD). Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process. Thorough knowledge of the international regulatory requirements for the conduct of clinical development programs. Knowledge of the drug development process from the perspective of both a contract research organization and drug development company. Ability to communicate in English, Spanish, and Portugese (preferred).
Experience	Minimum of ten (7) years relevant regulatory /clinical research experience in a pharmaceutical company/CRO including at least ten (10) years of Regulatory Affairs responsibility in a global environment. Minimum 5 years in supervisory role ability to lead and mentor staff. Demonstrated ability to lead and line manage staff in a global multi-office environment. Strong analytical skills. Excellent technical knowledge and understanding in the field of Global Regulatory Affairs. Experience in resource management. Excellent oral, written and presentation skills. Excellent planning and organizational skills. Proven interpersonal skills. Demonstrated ability to handle multiple competing priorities across clinical operating units. Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system. Demonstrated ability to function as a member of a senior global clinical leadership team. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.