CMC Regulatory Sciences Specialist - Post Approval Commercial Submission
Company: Regeneron Pharmaceuticals, Inc.
Posted on: May 6, 2022
We are currently looking to fill a CMC (chemistry, manufacturing
and controls) Regulatory Sciences Specialist for the Post Approval
Commercial Submission group. Regeneron successfully manufactures a
range of biopharmaceuticals for patients worldwide, including our
approved therapeutic proteins and those involved in clinical
studies. Our CMC Regulatory Sciences Specialists provide regulatory
support across Regeneron's sites. They assist through dossier
development for marketing applications, amendments, post approval
variations, and other regulatory submissions.As a CMC Regulatory
Sciences Specialist, a typical day might include the following:
- Preparing global CMC documents and sections for a variety of
commercial biopharmaceutical regulatory submissions, ensuring that
all submissions are complete, accurate, and meet relevant
- Handling and coordinating the authoring, review, and
finalization of CMC documents, and responses to CMC-related
inquiries from regulatory agencies, in accordance with submission
timelines, keeping all stakeholders, including outside partners,
informed of progress.
- Collaborating and developing excellent relationships with
functional area and cross functional teams, contract manufacturing
organizations, and global regulatory partners.
- Appling in-depth understanding of regulatory guidance and
regulations, as well as industry and government agency standard
methodologies and trends.
- Reviewing relevant CMC documents and reports for completeness,
accuracy and compliance with regulations and regulatory
- May coordinate and assign projects to specialists; may have
direct reports. This might be for you if you:
- Proactively identify issues and contribute to the development
of appropriate strategies to mitigate risk.
- Are willing to work and collaborate in an ambiguous and dynamic
- Look to contribute to developing CMC regulatory strategy.
- Have excellent written and verbal communication skills.
- Work independently, prioritize, coordinate, and complete
multiple projects within deadline while maintaining a high level of
attention to detail.
- Have knowledge of relevant drug development regulations and
guidelines (i.e. FDA regulations and ICH guidelines) as well as an
understanding of cGMPs (Current Good Manufacturing Practices).
- Possess strong skills in planning, critical thinking, and
problem-solving.To be considered for the CMC Regulatory Sciences
Specialist role, you must have the following; BA/BS degree
required, preferably in a scientific related field. Associate
Specialist level aligns with 0-2 years of relevant experience,
Specialist level 2+ years of relevant experience. At the Senior
Specialist level an advanced degree is preferred with 4+ years of
relevant experience or 5+ years of relevant experience with BA/BS.
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
Keywords: Regeneron Pharmaceuticals, Inc., Troy , CMC Regulatory Sciences Specialist - Post Approval Commercial Submission, Other , Troy, New York
Didn't find what you're looking for? Search again!