Manager CMC Regulatory Sciences Project Management

Rensselaer, NY, United States
Jan 02, 2021
Required Education
Bachelors Degree
Position Type
Full time
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Sciences team is comprised of hardworking professionals with multifaceted scientific backgrounds and experience. We are looking for a Project Manager to join the CMC Regulatory Sciences Project Management group, which provides support for the timely and efficient preparation of Regeneron's regulatory submissions, product specifications, and product quality reviews. This is a great role for someone who enjoys using program management knowledge to plan and lead the progress of pharmaceutical regulatory submissions for clinical and commercial programs.

As a Manager CMC Regulatory Sciences Project Management, a typical day might include the following:

  • Collaborating with cross-functional departments to plan, manage and drive project activities within agreed quality, scope, budget and time.
  • Building and maintaining positive relationships with a wide variety of internal and external partners.
  • Leading a team of project specialists and coordinators who ensure significant regulatory projects are on track.
  • Serving as the primary point of contact among cross-functional areas to facilitate the development and execution of regulatory strategy.
  • Anticipating and identifying potential risk to regulatory submission timelines.
  • Keeping management and others advised on progress of documents/regulatory outputs.
  • Facilitating and leading regulatory submission activity communication between global functional areas and corporate partners.
  • Delivering presentations for management and joint collaboration meetings.
This role might be for you if you:
  • Are adept at managing through influence as well as direct authority.
  • Are skilled at ensuring delegation to appropriate team members based on expertise.
  • Can balance a varied workload, ensuring it is prioritized and equitably allocated among the team.
  • Enjoy being in a highly visible role where you and the team can make a positive impact on our patients.
  • Consistently maintain professionalism in communication, maintaining composure under pressure.
  • Have outstanding written, verbal, and interpersonal communication skills with the ability to effectively interact with team members with tact and diplomacy.
  • Are a critical and analytical problem solver with strong planning skills.
  • Have the innate ability to guide the prioritization, coordination, and completion of multiple projects within tight timeframes, while maintaining a high level of attention to detail.

To be considered for this position, you should have a BA/BS, preferably in a scientific field; relevant experience may be substituted in lieu of educational requirement.
Applicants must have at least 6 years of work experience, of that, at least 4 years of relevant project management experience and 1 year of leadership/supervisory experience for Associate Manager. Applicants with at least 7 years of overall experience, 5 years of project management and 3 years of leadership/supervisory experience may be considered for Manager. Applicants with at least 8 years of work experience, 6 years of project management and 5 years of leadership/supervisory experience may be considered for Senior Manager. PMP certification preferred.
Level will be determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.