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Role Summary

ROLE SUMMARY

Experienced CMC professional serving as project leader responsible for the development of initial CMC regulatory strategies, submissions and compliance activities for development programs and commercial products supporting the Business Unit little to no supervision.

Provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities. Leads the initial preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans with little to no supervision.

Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions with little to no supervision.

Accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio.

May represent CMC during interactions with regulatory agencies and external partners either directly or in conjunction with Regulatory Affairs.

Operate with little to no supervision to resolve issues and manage regulatory risks and ambiguous situations within project teams. Initial investigation of opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems with little to no supervision.

Role Responsibilities

Serves as a CMC strategist and project leader for projects within the Business Unit portfolio, providing regulatory assessments and developing regulatory strategies with little to no supervision.

Acts as the global CMC representative within cross-functional project teams. Accountable for assigned projects and activities, completing work within assigned product portfolio, project teams, for multiple projects with little to no supervision.

Interprets CMC regulatory requirements for human health prescription combination products, develops strategies, assess risks and develops contingency proposals with little to no supervision. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation. Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.

Is responsible for the authoring and reviewing of CMC documentation, coordination and management of global submissions, including the assessment and management of the commercial license, maintenance of MMT site registrations and product compliance and management of change control.

Is responsible for collaborating effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the Business Unit portfolio. Develops initial resolution proposals for regulatory CMC/information management issues with project/program stakeholders. Displays a willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions.

Qualifications

The colleague will have BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree. Must have a minimum of 5-7 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience. Must have a minimum of 4 years drug substance or drug product development or manufacturing technical support experience. Experience with diverse dosage forms, particularly sterile combination products, is desirable.

The colleague will be an experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain. Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.

The colleague will have a sound understanding and functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with a clear understanding of drug development/commercial manufacturing of pharmaceutical products, including technical and scientific understanding of pharmaceutical drug development with technical writing skills. Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.

The colleague will have a clear track record of effective teamwork, collaboration, and communication, and also demonstrated leadership ability in a cross-functional matrix team environment. Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes.