Global Regulatory Lead - Senior Manager - Flexible Working Available
Assures that products are developed in line with the global registration requirements of targeted countries and obtains expedient registration of these products in a cost effective manner. Maintains registrations of existing products in compliance with applicable regulations.
· Develops and implements regulatory strategies for development projects and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities.
· Manages the preparation of registration packages and responses to deficiency letters to ensure effective presentation and quality. Negotiates and influences submission data requirements and deliverable dates with regulatory authorities and internal technical teams. Authors key pieces of regulatory submissions.
· Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
· Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
· Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs. Identifies new requirements or changing landscape and can lead implementation of these new or updated processes/requirements within the regulatory organization.
QUALIFICATIONS / SKILLS
· Interprets global regulations to assure regulatory compliance, minimize product cost and reduce development cycles.
· Negotiates reasonable and attainable regulatory strategies that are innovative and executable in commercial manufacturing facilities.
· Understands and can challenge scientific arguments, identifies regulatory scientific data needs and solves regulatory issues. Gains consensus to execute at project level.
· Influences the development of complex global products and improvements to existing products through thoughtful regulatory strategy which can increase sales and/or reduce compliance risk. A successful regulatory strategy can have a critical impact on eventual revenue by early approval with the best possible label.
· Suggests and implements system improvements to reduce cycle time and increate efficiency.
· Analyzes and interprets complex data across scientific disciplines.
Identifies gaps in submission strategy and executes plans to mitigate the risk to approval.
· Possess analytical acumen to influence scientists to present data to meet needs of regulatory agency or influence regulatory authority to accept alternate strategies.
Authority to Act:
· Has the authority to prepare and submit complex regulatory submissions.
· Makes independent judgments and decisions based on agency regulations, professional experience, and regulatory intelligence.
· Reviews meeting strategies with regulatory authorities with manager prior to execution.
· Bachelor's Degree - Required
· Master's Degree - Preferred
· Ph. D - Preferred
· Other (R. Ph.) - Preferred
· A degree in a science related field will assist in problem solving technical issues as they relate to product development, manufacture and global registrations.
· Significant experience in the pharmaceutical industry or relevant medical device experience as needed for the position.
· Proven experience in regulatory affairs, research and development or quality assurance/compliance.
· Experience working with regulatory agencies. Sound knowledge and demonstrated application of relevant portions of agency guidance and regulations.
· Able to challenge scientific arguments and construct complex regulatory strategy.
· Excellent oral and written communication skills.
· Good interpersonal skills.
· Proven negotiating skills.
· Strong understanding of business needs.
The closing deadline for applications is December 6th.
All applicants must have the relevant authorisation to live and work in the UK / US as applicable.