Associate Manager CMC Regulatory Sciences
We are currently looking to fill an Associate Manager CMC Regulatory Sciences position. This position is responsible for overseeing technical writing activities which include gathering input and data in order to write internal scientific reports and documents for pharmaceutical regulatory submissions.
In this role, a typical day might include the following:
- Oversees and assigns projects/workload to other technical writer(s).
- Independently prepares or assists with the preparation of a variety of CMC regulatory documents to support all phases of drug development.
- Collaborates with research and development and manufacturing personnel in the preparation and review of regulatory documents; providing feedback on format and content and guidance in general. Keeps management and others informed on progress of documents.
- Interacts with regulatory authorities from US, Canada, and other international health agencies in support of the CMC modules of new drug submissions, biologics license applications, amendments and other regulatory documents.
- Responsible for review and revision of product lifecycle documents including, but not limited to product specifications, validation protocols and reports, and process development reports.
- Maintain database of regulatory commitments to regulatory authorities and communicate within the organization to ensure compliance.
This role may be for you if you:
- Proven ability to formulate a compelling vision and develop a strategy with key stakeholders to achieve that vision.
- Highly effective in an ambiguous environment and able to produce maximum results with little direction and guidance.
- Demonstrated history of building and maintaining positive relationships both internally and externally.
- Strong ability to communicate at all levels with clarity and precision.
- Open and receptive to change while looking for opportunities to continuously improve processes.
- Strong understanding of quality principles in a regulated manufacturing environment helpful.
To be considered for this role you must hold a BS/BA degree; advanced degree preferred and at least 4 years of experience with biopharmaceutical equipment or manufacturing, along with at least 1 year leadership/supervisory experience.
Level is 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.