The Director, Regulatory Affairs - Global CMC will lead and support the CMC aspects of regulatory planning and execution for Venatorx’s early to late development assets working with the cross-functional development and CMC teams.
- Acting as the CMC regulatory expert for global project teams and being accountable for recommending and managing global CMC regulatory strategies, plans and activities.
- Coordinating, authoring/preparing and reviewing CMC sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments to ensure applicable regulatory requirements are met.
- Directing development of responses to all regulatory issues/queries involving CMC aspects of the development programs to achieve timely resolution.
- Understanding, interpreting and advising teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products to assess risk/impact on business and development program/s.
- Assessing data with technical functional expertise to solve problems and make good decisions for the overall business.
- Building partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
- Coordinating, authoring/preparing and reviewing documents to ensure timely filing of CMC regulatory submissions (including INDs/CTAs, NDAs/MAAs, amendments/variations, safety reports, annual updates and briefing documents).
- Guiding CMC stakeholders on regulatory issues and conducting impact assessment for manufacturing changes; maintaining records of the decisions per existing or new process to achieve compliance.
- Providing CMC review/input for clinical study protocols, clinical study reports, investigator brochures and other relevant reports.
- Maintaining current knowledge of relevant US and international guidance’s, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
- Ensuring compliance to global regulatory guidance documents, regulations and laws, as well as internal policies and procedures.
- BA/BS degree is required; Advanced degree (M.S., Pharm.D. or Ph.D.) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
- Minimum of 7-10 years of experience in CMC Regulatory Affairs or related experience in positions of increasing responsibility, preferable in the pre-marketing and post-marketing phases of development.
- CMC regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions.
- Extensive regulatory experience including IND/CTA, NDA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing complex regulatory CMC strategies with a proven track record of significant regulatory accomplishments. experience preferred.
- Experienced in Regulatory Agency meetings resulting in successful outcomes.
- Experience with global regulatory submissions and an understanding of worldwide drug guidelines and regulations. Drug approval experience preferred.
- Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP and CTD/eCTD, and US FDA CDER requirements for the drug approval process.
- Previous participation in preparing Regulatory submissions (e.g., IND, CTA, NDA, etc.)
- Solid understanding of the eCTD specifications for electronic submissions.
- Strong technical writing ability and previous experience in documentation preparation/publishing using Adobe Acrobat, preferred.
- Excellent oral and written communication skills with experienced communicating vertically and horizontally within an organization.
- Ability to rapidly understand and analyze complex problems/situations; active participation and the management of projects leading to solution development and implementation.
- Respectful and collaborative team player with an ability to think creatively outside the box, while ensuring transparency and clear decision-making.
- Some travel may be required.