Reports to the Director or Sr. Director of Regulatory Affairs. This position is responsible for the effective and efficient management of the regulatory staff at multiple sites. S/he mentors and provides regulatory guidance to team members. This includes projecting and achieving timely regulatory filings, the development of realistic regulatory timelines in the unit and project planning. The Sr. Manager interacts with all levels in the organization, including representing Regulatory Affairs in international and company forums. S/he participates in discussions with Sr. Management and provides strategic regulatory guidance. The Sr. Manager interfaces with regulatory agencies, primarily the FDA, as it relates to submissions and other relevant topics. Maintains regulatory compliance and provides regulatory guidance on development and marketed product issues.ResponsibilitiesThe Sr. Manager is responsible for effectively
Additionally, the Sr. Manager
- Managing and prioritizing the team's workload in accordance with departmental goals
- Helping staff to interpret changing priorities, processes and requirements,
- Leading the development of procedure or tools to increase work efficiency
- Motivating staff and maintaining the team's f ocus on departmental objectives
- Translating strategic goals into group and individual performance objectives
- Motivates and encourages by recognizing accomplishments
- Overseeing the preparation and filing of high-quality submissions to regulatory authorities
- Ensuring that all submissions are filed in accordance with predetermined timelines
- Align resources and develop processes to ensure timely submissions
- Providing expert regulatory strategy/guidance to staff and inter-disciplinary project teams
- Applying expert knowledge of industry conditions and opportunities for competitive advantage to make business recommendations
- Anticipating changes in the regulatory environment and the potential impact to FK, shaping internal strategies accordingly
- Interacting with regulatory agencies regarding submission strategy
- Proposing and negotiate complex and technical issues to a successful outcome
- Providing comments and perspective on proposed regulations to influence outcomes
- Ens u r ing that department management is aware of team activities and progress
- Developing staff and conducting mid-year and annual reviews of staff
- Promptly recognizing performance gaps and resolve them before they impact business results
- Supportomg learning opportunities and mentors others, encourages employees to take on stretch assignments
- Clearly and convincingly communicates complex issues to internal and external customers
- Managing timelines and performance for staff at multiple sites and ensure collaboration and consistency across sites within processes.
- Will achieve and garner the respect of others within and outside the department on matters related to development and marketed drug applications
- Recognize early developing adverse trends or gaps and brainstorms practical solutions for both short and long-term corrective actions.
- Collaborats with other FK units in providing RA strategy/expertise
- Serve as a technical back up to Director/Sr. Director in matters involving Regulatory strategy
- Serve as a backup to departmental functions (meetings, presentations, etc.)
- Establish new procedures while working in unfamiliar or gray areas of Regulatory
- Propose and negotiate complex and technical issues to a successful outcome
- Provide comments and perspective on proposed regulations to influence outcomes
- At minimum, a Bachelor Degree in a scientific discipline and 6-8 years' experience in pharmaceutical Regulatory Affairs with past leadership experience. Relevant experience in other technical areas within the pharmaceutical industry may be considered.
- Experience in preparing and filing complete A/NDA's, Supplements, Amendments and Annual Reports to FDA. Relevant experience in preparing documents that support regulatory filings may be considered.
- Previous leadership experience required, with experience in managing multiple levels of staff at multiple site is preferred.
- Demonstrated effective oral and verbal communication skills, attention to detail, and superior organization skills.
- Demonstrated in depth knowledge in FDA regulations, ICH guidelines, and cGMPs.
- Must be detail oriented, self-motivated, organized and have the ability to prioritize work.
- RAC beneficial
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.