Job Summary:

This position is responsible for providing leadership for China CMC regulatory activity of biological drug in the portfolio.  This individual will be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC submissions, and interacting with Health Authorities to meet the aggressive urgent submission timelines for the assigned projects, interacting with China national testing agency (e.g NIFDC). The individual will also contribute to regulatory process optimizations on relevant topics.

Responsibilities:

1.Management of TeamRepresents RACMC section in DSCN RACMC department and provide CMC regulatory guidance and strategy.  Manages team providing guidance on overall development strategy and expert CMC regulatory and technical advice on developmental issues within projects.  Provides for review of submission dossiers for accuracy, high quality and regulatory compliance.

2.Health Authority InteractionFor assigned projects, leads the CMC Health Authority meetings as project member to include: serving as the primary company liaison for regulatory interactions with Chinese Health Authorities for CMC issues; identifies critical issues with the development team for discussion with the Health Authority; leads the document preparation, review and finalization of the briefing books; prepares the development team for the Health Authority meeting; leads the Health Authority meeting; negotiates with the Health Authority when needed by DS; leads the preparation and finalization of the meeting minutes.

3.Development Project AssignmentsDevelops strategy and provides the submission content template to the development team prior to major submissions and leads the development team in the preparation of the CMC regulatory submissions-i.e., INDs/Amendments/NDAs/Supplements, and DMFs to include scientific and regulatory review for accuracy, soundness and regulatory appropriateness.  Authors regulatory/technical documents in support of regulatory submissions, where necessary. Assures regulatory submissions are completed within the project timeline.  For major submission, coordinates the preparation of the detailed risk assessment and works with the technical groups to assure successful implementation of mitigation measures.  For Health Authority queries during the review, manages the responses by providing the tracking list to include regulatory recommendations, assignment of authorship, and task completion dates.  Assures completion and timely submissions to all Health Authority CMC queries.

4.Committee AssignmentsServes as RACMC member, support of industrial activities such as RDPAC CMC taskforce as needed.

5.Subject Matter ExpertServes as the regulatory CMC expert to project team for the solution of complex technical issues based upon expert scientific knowledge and experience in past regulatory precedent.  Maintains an expertise in areas focusing on chemical drug and biologics.

6.Marketed ProductsAssesses change controls for determination of submission type including estimated approval timeframe and regulatory document requirements.  Prepares, authors where necessary, reviews and compiles supplements/variations to assure timely approval by Health Authorities.

Qualifications:

1.Master’s degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus.

2.Minimum of 5-10 years of experience in the pharmaceutical industry, and minimum of 5 years of experience in global RACMC with emphasis on late stage CMC drug development and marketing authorization applications on chemical drug and/or biologics in China.

3.Successful track record in preparation, management of review and approval of BLA/NDA with Health Authority, with writing ability for China specific documentsExperience of working in global environment in interdisciplinary teams.

4.Prefers analytical background for QC testing support, with good understanding of Chinese Pharmacopeia requirements, especially biological analysis or Chemical product analysis background.Background of working in Chinese HA is a plus.

5.Experienced in supervising, coaching, motivating, training and mentoring junior staff members including effective work delegation.

6.Advanced and comprehensive knowledge of regulations/guidance documents and corporate industry standards. Solid knowledge of regulatory submission procedures including CMC requirements for filing and maintaining INDs/NDAs /DMFs.

7.With strong scientific technical knowledge, provide committed value-added effort in support of development and commercial projects.

8.Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization.

9.Excellent written and oral communication skills in English.