Job Description
The Associate Manager/Manager uses extensive program management knowledge within the drug development industry to lead programs of sophisticated complexity and large scope, such as late stage clinical development or commercial. The successful candidate will also have responsibility for leading a group of CMC Team Leads and in this case be expected to apply expertise within the drug development industry to guide team members to plan, coordinate and own the progress of assigned CMC Programs. A typical day might include, but is not limited to, the following: Liaising with Global CMC Project Management and production functional areas in order to facilitate the advancement of Drug Substance Manufacturing Projects. Providing support to the Global CMC PM team and supervisor in assessing resource needs to achieve project timelines and quality milestones. Serving as liaison between the RAH-IOPS site, the RAH CMC site licensure team and all Global CMC project team members. Coordinating the CMC regulatory activities required for submission of license applications and other regulatory documents to government agencies in clear alignment with the Global CMC Project Plan. Ensuring effective, accurate and timely communication across functional areas and partners within the CMC Project/Program, serving as a primary point of contact among Raheen functional areas for CMC Project-related issues. Presenting responsibilities to CMC Project management, Global CMC meetings, Manage Supply, and weekly/monthly project updates. Facilitating leadership matrix style organization with shared resources; providing expert guidance and mentorship to others through influence rather than direct authority Accountable for technical performance and results of a team; proactively and patiently identifies and resolves individual and team performance issues; utilizes expert conflict resolution skills. Initiating and owning the decision-making and risk mitigation process Leading the development of tools and mechanisms for supervising progress and drives effective out of the box problem solving with cross-functional teams and area managers. Driving of information/experiences (Lessons Learned) across communities of practice, business units and networks on innovative approaches in knowledge sharing supporting the global Knowledge Management initiative. This role might be for you if you: Have the ability to gain acceptance of others in sensitive situations and exert influence on the department and the business. Have excellent written and verbal communications skills crucial. Have the ability to research, analyze and extrapolate critical regulatory information Have good understanding of the drug development and commercialization process, with a focus on CMC Have the ability to maintain integrity and honesty at all times Are a passionate people leader, can build positive relationships, with the ability to effectively collaborate with a range of individuals across the organization at all levels To be considered for this position BS/BA in Biological Science or related field. For Associate Manager level, you must have 7+ years' experience with at least 2 years leading teams. For Manager level, you must have 8+ years experience with at least 3+ years leading teams. JOBSIEST Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.