- Regulatory strategy liaison with global Analytical R&D (ARD) project teams including timely communication of applicable regulatory intelligence while advising/supporting project teams to ensure consistent application of internal processes
- Drive a cohesive control strategy and specification approach for NCE portfolio programs, mentoring/coaching teams via CSR/SAT process
- Act as single point of contact for ARD project teams in QDP audit process: interfacing with QA auditors, supporting document roadmap compilation, resolving issues/observations and process improvements
- Evaluate and translate regulatory feedback into practical knowledge by authoring internal guidance documents, procedures, work instructions, and white papers to support ARD’s business
- Identify and execute initiatives that streamline and simplify ARD’s analytical and regulatory processes in support of a diverse development portfolio while coordinating broad internal CMC stakeholder alignment
Management & Development of People / Resources:
- Individual contributor role responsible for mentoring junior colleagues, interns, and summer workers
Innovation & Scientific Leadership:
- Contribute to ARD global regulatory policy review and region-specific implementation strategies with broad internal CMC stakeholder reach on topics including analytical method development, validation, and transfer; specifications and control strategies; stability testing; and review and implementation of compendial changes.
- Maintain ARD regulatory intelligence information capabilities
- Understand and consolidate global ARDs interests / needs on regulatory and data strategy topics
- Develop creative ideas to make external and internal guidance documents, procedures, work instructions, and white papers etc. available and implemented to ARD project teams
Minimum Education & Experience Required:
- Bachelor’s + 14 years, Master’s + 12, PhD + 6 years in pharmaceutical sciences, chemistry, food sciences or related field is required. Advanced degree is preferred.
- Must have a thorough understanding of small molecule (NCE) analytical development and deliverables required to support end-to-end pipeline programs.
- Flexibility and ability to look/think outside-the-box for new ways to work in ARD based on changing external regulatory landscapes and industry trends.
- Exhibit passion and energy to build consensus, overcome resistance, and drive change (be a change agent) within ARD and across a broad cross-functional stakeholder group while embracing a global mindset.
- Builds strong relationships with peers to create and implement cross-departmental analytical strategies.
- Knows the business to influence long-range analytical strategy.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Deals comfortable with uncertainty, ambiguity, and risk to make decisions having mid-term impact. Ensures alignment with corporate/regulatory policies/standards.
- Steps up and takes leadership to implement changes in the face of organizational or personal challenges.
- Raises the bar and drives the function to efficient/reliable execution.
- Learns fast, grasps the essence and can change course quickly where indicated to manage and prioritize resources & timelines across a wide range of development programs/scientific initiatives within area of responsibility.
*Job level will be commensurate with academic and work experience.*
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced