Dechra · 2 days ago

Principal Scientist, Regulatory Affairs CMC

United States

Full-time

Remote

Senior Level, Lead/Staff

6+ years exp

Maximize your interview chances

BiotechnologyPharmaceutical

Culture & Values

Hiring Manager

Patryk Wikiera

Insider Connection @Dechra

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Provides effective Regulatory CMC representation for development projects and commercial stage products, and acts as a key player in interactions with regulatory agencies on CMC related topics, in collaboration with global regulatory teams.

Effectively interprets and applies regulatory guidance and provides regulatory recommendations and solutions to key stakeholders.

Drives alignment of regulatory CMC strategy within the RA department and other functions. Effectively communicates regulatory strategy consistently to stakeholders.

Actively collaborates with Global Regulatory CMC, Product Development teams, Technical Operations (internal and external manufacturing), and Quality to develop and execute robust regulatory strategies and risk mitigation for product development, registration, and post-marketing life cycle management.

Leads and manages the development and preparation of CMC-related submission documents and ensures they meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle. The submissions include, but are not limited to, new drug applications (e.g. NADA, ANADA, etc.) in the Common Technical Documents (CTD) format, investigational new animal drug applications (e.g. INAD, JINAD), supplemental filings (e.g. PAS, CBE), responses to agency comments, and annual reports.

Leads best practices for regulatory CMC compliance activities in cooperation with local and global Quality including, but not limited to, change controls, post-marketing commitments, product quality complaints, and regulatory inspections.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

CMC regulatory affairsFDA regulationsGMP standardsRegulatory strategyRegulatory complianceProject managementManual filing systemsElectronic filing systemsMentoring

Required

A minimum of 6-8 years in CMC regulatory affairs within the pharmaceutical industry, specifically with US-FDA regulations (CVM experience preferred).

Strong understanding of GMP standards and FDA regulatory requirements for CMC.

Ability to work methodically and flexibly, with a proven capacity to set up and maintain both manual and electronic filing systems.

Exceptional attention to detail, with strong decision-making skills and resourcefulness.

Effective listening, verbal, and written communication skills, with the capability to confidently and credibly deliver internal and external presentations.

Excellent interpersonal skills to establish and maintain effective relationships at all levels.

Proven ability to plan, organize, and prioritize workload independently to meet deadlines, including support for supply chain maintenance.

Strong ability to manage and progress multiple projects concurrently.

Demonstrates respect, sensitivity, and professionalism in interactions with colleagues and external partners.

Maintains a high level of confidentiality and discretion.

Ability to lead project teams and mentor/train less experienced colleagues.

Shows initiative in seeking knowledge and learning independently.