Regulatory Affairs Manager - Submissions Job

Job Title:
Regulatory Affairs Manager - Submissions

Req #:
5344BR

Job Description:
Position Summary: The Global Regulatory Affairs Submission Manager is responsible for working to execute timely and accurate product registrations. Responsible for working with the Advertising and Promotion Senior Manager and Labeling Senior Manager to ensure that all advertising, promotion, and labeling materials are submitted in accordance with post marketing reporting requirements to the appropriate Regulatory Authorities where applicable. Works closely with outsourced providers to oversee the submission of timely annual reports and the transmission of electronic submissions for pharmaceutical drug products. Specific

Job Duties:
* In conjunction with the Global Regulatory Support Services Director, responsible for developing and implementing the pharmaceutical regulatory submissions strategy that define Bausch & Lomb's approach for regulatory submissions and promote speed to market * Develop submission schedule aligned with product development pipeline to ensure timely submission and approval of applications, amendments, supplements, and other regulatory correspondence * Manage the compilation and publishing process for routine and regulatory submissions, including oversight of work being performed by contract vendors * Liaise with country-specific regulatory affairs submission personnel * Provide information for pharmaceutical product registrations * Responsible for preparing for global product registration variations and product renewals * Managed assigned personnel Technical Competencies: * Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations * Knowledge of current and emerging issues and trends of the regulatory environment within specialty area and ability to integrate such within the regulatory affairs organization * Knowledge of domestic and international regulations relating to the submission and regulatory approval * Ability to compile and file submissions to Global Regulatory Authorities * Knowledge of document management and electronic publishing systems (i.e., Documentum, Core Dossier, MS Office applications, Adobe Acrobat, MS Project). * Strong general technology skills and abilities * Capability to react quickly to changes in the regulatory environment and make decisions to minimize risk to the business * Ability to team with cross-functional groups in a global regulatory affairs organization * Capability to interpret regulatory authority policies and guidance and correctly apply them as appropriate to the submission process Professional Competencies: * Demonstrated ability in analytical reasoning and critical thinking skills * Strong capability to contribute and lead in a team environment * Strong interpersonal skills * Excellent communication skills; both oral and written * Demonstrated ability to contribute to a continuous learning and process improvement environment * Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies

Qualifications
* 8+ years relevant pharmaceutical industry and regulatory experience * Pharmaceutical submissions experience * Bachelors degree * Advanced degree a plus (PhD, MD, MS, PharmD, or equivalent)

Work Location NJ - Madison Relocation Available Yes

Status Full-Time

Nearest Major Market: New Jersey
Job Segments: Management, Manager