Senior Manager, Regulatory Affairs, CMC

Celcuity•Minneapolis, MN

60d•$165,000 - $175,000•Remote

About The Position

We are seeking a Senior Manager of Regulatory Affairs, CMC who will report into the Associate Director of Regulatory Affairs. You will be responsible for working collaboratively with internal team members and external contractors to provide regulatory guidance while ensuring ongoing compliance with the development of oncology products. The individual will be responsible for developing collaborative and productive partnerships internally, as well as externally with key vendors to produce high quality regulatory submissions. Knowledge of CMC global regulations is necessary to provide CMC regulatory affairs support to ongoing global clinical trials and to review global submissions to these trials. This position will be responsible for establishing standards and performing submission activities in a high-quality manner including original writing and preparation of CMC regulatory documents, creation of regulatory project submission timelines, overseeing submission tracking, document collection, and archival to assure timely, compliant, and high-quality regulatory submissions management.

Requirements

Bachelor's degree in a science or health-related field (like biology, chemistry, or pharmacy); or relevant experience; preferred.
Eight plus (8 +) years of submission/publishing Regulatory Affairs, Regulatory Operations, or Regulatory Project Management experience in a biotech/pharmaceutical setting.
Excellent command of GXPs (eg, GMPs, GLPs and GCPs).
Demonstration of cross-functional understanding related to drug development
Understanding of all International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA guidance relevant to electronic regulatory submissions.
Experience and knowledge in the preparation of global regulatory submissions with primary focus on electronic publishing of US IND and/or NDA sequences (additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) helpful).
Ability to work both independently with direction and within project teams and see all projects through to their completion.
Excellent verbal and written communication skills.
Strong organizational skills, including the ability to prioritize workload.
Strong people skills and the ability to deal effectively with others.
Ability to meet deadlines and perform multiple tasks in a fast-paced setting.
Maintain a positive, approachable, and professional attitude.

Responsibilities

As a member of the CMC project teams, provide strategic CMC regulatory leadership project teams and external stakeholders to support global development and commercialization of drug candidates.
Responsible for writing and maintaining CMC sections of INDs and IMPD's for global CTA's, while ensuring complete, compliant, and timely submissions.
Provide hands-on support in the generation of CMC documents, responsible for compilation, review, approval and submission of high-quality CMC related sections of INDs/CTAs, NDA/MAA, including responses to questions from various regulatory authorities, working in collaboration with SME's in Pharmaceutical Development, QC/QA, Supply Chain and other CMC business partners.
Maintain responsibility for all CMC Regulatory timelines including developing timelines for IND/CTA (IMPD)/NDA/MAA submissions (new, amendments, supplements, responses to queries), updating SmartSheet, communicating, and escalate any timeline issues to management toward a successful on-time filing.
Act as the regulatory representative on clinical study teams and product development teams providing guidance on regulatory CMC guidance, under the supervision of Regulatory Affairs leadership.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed pharmaceutical development (CMC) changes and provide strategic regulatory guidance to enable global implementation.
Evaluate business impact, through regulatory intelligence, all changes related to regulatory CMC regulation, or adoption of new regulation which impact CMC processes and/or CMC strategy.
Interacts with vendors as needed in support of electronic publishing and other aspects of regulatory operations as well as regulatory submission preparation as needed.
Performs detailed quality reviews of published submission output to ensure compliance with Regulatory Standards, as required.
Tracking and archiving submissions, correspondence, and commitments with health authorities as needed.
Develop and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
Ensure the company is adhering to all applicable government regulations, submission regulations and guidelines.
Other duties as assigned.

Benefits

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package.
Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

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