Senior Manager, Regulatory Sciences

Job Title: Senior Manager, Regulatory Sciences

Job Description:

POSITION PURPOSE:

This individual is expected to actively contribute to the development and implementation of scientific/CMC/ regulatory strategy for products in development and post-approval. This individual will also coordinate all aspects of Scientific/CMC/regulatory submissions relevant to their assigned projects or programs and serve as the scientific representative on relevant project teams.

ESSENTIAL FUNCTIONS:

·        Knowledge of the chemistry and/or biotechnology related to manufacturing and control of active pharmaceutical ingredient (API) and drug product of small molecules and/or biologics.

·        General expertise in biotechnology or chemistry, in-process control, analytical testing and validations.

·        Ability to interpret a variety of scientific data and technical instructions in mathematical or diagram forms to identify problems, collect data, establish facts, and draw valid conclusions.

·        Ability to draft, manage and coordinate assigned regulatory submissions.

·        Knowledge of GLP and GMP compliance, FDA guidelines and federal regulations

·        Knowledge of pharmaceutical product development.

DAILY RESPONSIBILITIES:

·        Serve as the regulatory representative on project teams and provide regulatory guidance for CMC, clinical and nonclinical product developments.

·        Assist in designing experimental study protocols, comparability protocols, evaluate analytical data, and write reports; Provide scientific and regulatory support for analytical and bioanalytical method development and validation activities.

·        Review Batch Record, Certificate of Analysis (CoA), and CMC reports including analytical, validation, stability, technical change, out of specification, deviation, investigation, corrective and preventive action reports.

·        Support CMC development as needed, including strategy for any post-approval CMC changes, selection of the contract manufacturer and regulatory submission activities.

·        Review the results of experiments related to the chemistry and/or biotechnology of commercial and under development company products and collaborate to the design of additional experiments.

·        Prepare, collect, review and assemble technical documentation required for writing annual reports, and CMC sections of IND, NDA, SNDA, and BLA.

·        Write CMC sections of assigned regulatory submissions.

·        Coordinate with other authors and Regulatory Operation team for assigned submissions to ensure timely preparation

·        Manage assigned research projects from a regulatory project management perspective.

·        Assist in conducting on-site technical audit to contract laboratory and manufacturing facilities.

·        Review supplier and quality agreement from contract laboratories and manufacturers.

·        Assist in due diligence activities for product acquisition reviewing technical documentation related to product manufacturing.

·        Monitor Federal Register regarding regulatory requirements which may impact pharmaceutical drug development and commercial drug products of the company.

·        Liaise with external companies and internal departments to ensure scientific soundness and regulatory compliance.

·        Other duties as assigned.

SPECIFIC JOB KNOWLEDGE, SKILL AND ABILITY:

·        At least 8 years of experience in the pharmaceutical industry

·        B. S. or M. S. in Chemistry or Biochemistry. Advanced degree is plus.

·        Strong analytical and problem-solving skills. Experience with product characterization and analytical development and validation

·        Proficiency with Regulatory writing

·        Proficient with MS Office.

·        Ability to multi-task

·        Demonstrated leader with the ability to work effectively in a collaborative work environment.

·        Strong verbal and written communication skills.

Travel requirements: Must be able to travel 10-20% of the time.