The Opportunity: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: - You will serve as CMC-regulatory lead for assigned projects.
- Develop and execute CMC global submission plans and timelines in accordance with project goals
- You will lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development leads/SMEs.
- You will be responsible for coordination of responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs leads/SMEs.
- You will lead 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.
- You will lead and manage CMC-regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, in conjunction and consultation with CMC leadership.
- You will keep abreast of regulatory guidance and technical/scientific developments relevant to projects.
Competencies:- Strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions.
- Proven ability to lead and manage regulatory CMC projects with minimal supervision
- 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+ 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 Module 3 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.
- Authoring experience of CTD Module 2 & Module 3 sections.
Estimated Salary Range: [$145,000 - $207,000].
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.
#BP1
