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Head of Post Marketing - CMC Regulatory
The company is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. The unique SIMPLE Antibody™ platform and suite of Fc engineering technologies combined with the complementary expertise of the people enabled them to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
KEY ACCOUNTABILITIES AND RESPONSIBILITIES:
Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support the company’s portfolio marketed products for local and global filings. The candidate will be responsible for assuring development and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out to other territories world-wide. Critical to this role are strong CMC regulatory strategy and leadership skills.
- Lead the global post-marketing CMC strategy and CMC regulatory team.
- Provide CMC regulatory affairs leadership, oversight and strategy in support of company products, including but not limited to CMC regulatory strategies, regulatory requirements in global and regional markets, regulatory strategic development plans and risk assessments, and advice on Health Authority interactions.
- Lead Global Health Authorities interaction preparations on CMC strategy topics.
- Provide guidance on the scientific/technical requirements for CMC and GMP related submissions to pending BLAs, MAAs and Life Cycle Management activities (annual reporting, variation planning and filing, change impact assessment).
- Ensure post-marketing commitments strategy, follow-up and submission activities are planned and executed;
- Review CMC and GMP related submission documents to assure compliance with regulatory standards and scientific/technical requirements and ensure their appropriateness for use in global regulatory submissions.
- Ensures global CMC regulatory intelligence is built and captured across global CMC regulatory requirements.
- Performs risk analysis for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues as required.
- Establishes strong cross-functional partnerships to ensure collaboration with key internal stakeholders (RA, CMC, Supply Chain, Quality), and external organizations (contract manufacturers, regional regulatory partners etc).
- Ensures goals are met, processes are aligned to ensure efficiencies and to promote collaborative global cross-functional relationships.
- Be proficient in the tools and systems needed for the function including and not limited to Veeva RIMS and Veeva Quality docs – continuously seeking efficiencies in using these
- In-depth knowledge of global CMC regulations for biologic compounds, as well as devices, and the Module 2/Module 3 eCTD requirements.
- Combination product experience desired (Prefilled drug delivery systems, drug/device systems) is a plus.
- Experience in the biologic life-cycle activities desired.
Comprehensive knowledge of biologic and drug development process, pharmaceutical technology, manufacturing processes, GMP and related issues.
- Highly knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).
- Strong proven hands-on CMC Regulatory Affairs experience and knowledge of CMC regulatory submission requirements for global filings (FDA and/or EMA, etc.) is required.
- Strong understanding of pharmaceutical development, the regulatory environment, project management, and medical terminology.
- Have a solution-oriented approach to problem solving;
- Ability to work on complex projects and within cross-functional teams with minimal supervision
- Proactive strategic thinker; Operationally minded
- Strong analytical, problem solving, organizational and negotiation skills.
- Strong collaborative inter-personal, communication, presentation and meeting leading skills.
- Strong ability to work in a project-based environment and across cultural lines.
- Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
- 15+ years of experience in the pharmaceutical/biotechnology industry, 10 of which are in CMC Regulatory Affairs.
- 8+ years Leadership/management of Regulatory CMC activities and demonstrated organizational/planning skills.
- Master degree or PhD in biotechnology, pharmaceutical sciences, biological science