Subhan M. Email & Phone Number

Cincinnati, Oh, Us

Boston, Massachusetts, Us

Lawrence Township, Nj, Us

New York, Us

PharmaPath focuses solely on helping students and professionals learn about what options they have in the world of Biotech/Research&Development/Pharma/Med Devices. Reach out if you need help in understanding functional areas, CV review, CL review, LinkedIn review, and mentoring on proper communication using the STAR method variations. We work to enhance personal branding and communication. We do not do company referrals or assist with recruitment efforts. We do not provide company consulting or anything outside of helping students. This is strictly just educative for students and professionals! :)Reach out if you need assistance and advice!

Morrisville, Nc, Us

● Provided consulting as a regulatory affairs strategist for various different projects including a GAP Analysis, IND submission, pre-IND submission, and routine IND Maintenance for multiple indications across various TAs. ● Submitted and led the organization of 2 pIND meeting requests including their meeting information package submissions● Liaised with multiple clients that had separate regulatory hurdles and projects focusing on various disease states. ●Served as a project director for an IND submission with tasks including scheduling/leading routine weekly client calls with the clinical/regulatory teams, initiating draft reviews of M1, M2. M3, M4, and M5 documents, and scheduling kick off meetings. ● Participated in 2 separate IND submission 30 day review periods leading the FDA responses to several time sensitive information request documents (1.11.3, 1.11.1, 1.11.2).

Lianyungang, Jiangsu Province, Cn

■ Managed a diverse portfolio of novel therapeutic candidates targeting the HER2 class of oncologic diseases including breast cancer.■ Conducted direct interaction/negotiation with regulatory authorities (e.g. FDA) via FDA Type A, B, and C meetings. ■ Facilitated the organization, content, and submission of critical regulatory submissions including Investigational brochures, annual reports, briefing books, and protocol submissions. ■ Drafted, reviewed, and coordinated submission of strategic submissions including Orphan Drug Designation Applications, Pediatric Study Plans (PSP) Pediatric Investigational Plans (PIP).■ Represented GRA as a core member of the cross functional project team and Global Brand team and provided regulatory input for the project(s) globally. In this capacity, the GRL is the single point of contact for the business on regulatory issues for the project(s).■ Ensured the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for products and is accountable for developing and maintaining a global regulatory product strategy plan.■ Ensured a properly functional regulatory sub-team. Facilitates the development and implementation of local regulatory strategy working with the regulatory platforms.■ Presented the global regulatory strategy/position to senior management / governance committees as needed.■ Worked with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP.■ Ensured timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback is then interpreted and the impact on the project assessed. ■ Ensured compliance with all internal and external requirements and procedures and suggests improvements.■ Chairperson for the Breast / Lung Cancer Portfolio for Ex USA / China■ Responsible for Oncology products and excelling programs between USA, ex USA, and China.

Cambridge, Ma, Us

Durham, North Carolina, Us

■ Assisted in Sterile preparation for a 1000+ bedroom hospital.

Carrboro, Nc, Us

Raleigh, Nc, Us

Worked as a part-time consultant for 2 pharma companies [Assignment: DELAQUA, Chapel Hill, NC]■ Supported publications, medical conference staffing, advisory boards, and speaker training.■ Maintained scientific and clinical knowledge base by dissecting clinical trials.■ Conducted primary/secondary market research to assess value propositions and new therapeutic indications.[Assignment: MUCOMMUNE LABS, Chapel Hill, NC] ■ Helped write 40-page grant proposal yielding $3M in funding for company’s Phase 1 birth control clinical trial■ Helped develop clinical trial protocols for preclinical and Phase 1 medical device trial.■ With assistance from Category Clinical Research/Development Director, ensured content of clinical trial protocols, reports, disclosures, and publications were medically and scientifically robust.■ Developed, improved, and executed research plans and studies using established scientific methods and protocols.■ Utilized eCTD and module 3 writing platforms for regulatory submission narratives.■ Wrote, prepared, and submitted documentation to support clinical development.■ Submitted medication dossiers, developed scientific presentations for key opinion leaders, and conducting scientific reviews.

Chapel Hill, Nc, Us

■ Conducted complex literature database searches via PubMed, etc. to aid preliminary coding of a potential virtual patient software and educational tool for students and professionals throughout the world.■ Helped with coding and implementation of software technology to make simulations that utilize physiological and behavioral modeling of virtual humans.

Philadelphia, Pennsylvania, Us

■ Conducted biopharmaceutical research studying muscle-specific ubiquitin ligases in cardiac autophagy clinical trials.■ Interviewed patients, took vital signs, performed and blood draws, and recording adverse events (AEs).■ Interpreted protocols and advised treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.■ Served as a resource to CRAs/CRCs assisting with correction of case report form (CRF) errors compared to source documents

Chapel Hill, Nc, Us

■ Developed, coordinated, and implemented monitoring strategies essential to the successful management of clinical trials conducted by Principal Investigators (PIs).■ Conducted clinical monitoring of chromium cancer/oncology trials integrating knowledge of ICH and local regulations.

Doctor Of Pharmacy - Pharmd, Pharmacy

Bachelor Of Science - Bs, Biology ; Minor In Chemistry