Senior Director Regulatory Affairs CMC
VenatoRx Pharmaceuticals, Inc.
Location
Malvern, PA | United States
Job description
The Senior Director, Regulatory Affairs CMC will lead/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.
Duties and responsibilities Responsibilities include:
- 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.
Qualifications Candidate requirements:
- BA/BS degree is required; Advanced degree (M.S., Pharm.D. or Ph.D.) in scientific, Regulatory Affairs, or related pharmaceutical field is preferred.
- Minimum of 10+ years of experience in CMC Regulatory Affairs or related experience in positions of increasing responsibility, preferably 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, and 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 experience communicating vertically and horizontally within an organization.
- Respectful and collaborative team player with an ability to think creatively outside the box, while ensuring transparency and clear decision-making.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law. For more information, please check out our website:
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