As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role: - With minimal supervision, accountable for developing and leading the execution of regulatory CMC investigational, registration and/or post-approval strategies for Relay's development programs/products.
- Develop and execute CMC global submission plans and timelines in accordance with project goals
- Strong and deep foundational understanding of global RA CMC regulations and guidelines.
- Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance.
- Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.
- Apply global regulatory CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Responsible for leading and coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.
- Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
- Responsible for CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC/PD, regulatory affairs and/or program management, as applicable.
- Lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, as applicable, in conjunction and consultation with CMC leadership.
- Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within PharmDev and Regulatory Affairs Teams, as appropriate.
- Keep abreast of regulatory guidance and technical/scientific developments relevant to projects.
Competencies:- Strong background in CMC-regulatory affairs with focus on small molecule (preferably solid orals: tablets, capsules) clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions.
- Proven ability to lead and manage regulatory CMC projects independently. Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
- In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH).
- Positive attitude, energetic and proactive.
- Strong technical writing and document review skills.
- Excellent organizational skills, ability to multi-task and prioritize assignments, operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
- Strategic thinking capabilities with forward looking perspective and ability to find solutions, in alignment with management and program goals, strong communication, planning, and collaboration skills
- Attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary internal and external teams at third parties.
- Ability to effectively manage multiple projects with competing priorities.
Your Qualifications: - Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields.
- Minimum of 8-10+ years of relevant experience in regulatory-CMC and/or within CMC function (e.g. analytical, formulation and process development, QA, QC) in the biotech/pharmaceutical industry with a focus preferably on CMC for small molecules and oral solid products.
- Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance.
- Knowledge of eCTD Modules and QOS requirements for INDs/IMPDs and NDAs/MAAs.
- Experience managing submissions in RIM Veeva or equivalent; document formatting/Quality Control compliant with eCTD templates / requirements.
Estimated Salary Range: [$143,000 - $233,000].
The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.
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