VP Regulatory Affairs

Key Skills

Aartificial intelligence, Data science techniques, Effective communication skills, Management, Regulatory Compliance

Job Description

We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.

Global CMC Regulatory Affairs Vice President Biological (VP)

The Global CMC Regulatory Affairs Vice President Biological is responsible for developing global CMC regulatory strategies and content plans for a portfolio of biological products according to scientific/risk-based regulatory strategies.

The Vice President:

• Approves regulatory strategy and communicates critical issues to Senior Management.

• Ensures the development strategy meets global regulatory requirements over the lifecycle of the product.

• Ensures CMC/VST regulatory strategy is in alignment with global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Quality Target Product Profile (QTPP).

• Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).

• Establishes regulatory policy for the Company.

• Participates as the Regulatory CMC Lead on SLT supply chain Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.

• Escalates issues to Regulatory Affairs Management that affect registration, regulatory compliance, and continued lifecycle management of the product.

• Reviews and approves regulatory dossiers and communication for submission to Health Authorities.

• Actively drives participation on Global Regulatory Team(s) as needed to develop global marketing approval submission plans.

• Oversees that accurate regulatory assessments of chemistry, manufacturing and controls changes to teams/projects and regulatory planning and implementation is excecuted.

• Has broad expertise in Regulatory Affairs (focussing on Biologicals, pre-approval and post-approval).

• Has a proven track-record to use innovation approaches to enable the departemental goals improving cost and quality

• Participates in and conducts due diligence/licensing evaluations as needed.

• Manages a medium size organization and staff, including objective setting and career development activities and creating strategies to drive productivity and continious improvement.

• Represents CMC Regulatory Affairs Department on global teams as well as different governance committees.

Degree of Independence:

• Able to lead project team and assign roles and responsibilities; makes decisions

• Independently reviews submissions.

• Approves regulatory submissions.

• Demonstrates innovative thinking to achieve results and drive introduction of new technology in CMC regulatory (AI, Data Science, Data driven submissions).

• Formulates and approves recommendations on critical regulatory issues.

• Aligns and gains agreement of GRT position with Therapeutic Area regulatory leadership to ensure CMC/supply chain strategy is aligned with product goals and global regulatory strategy.

Works within established priorities to meet Business Unit and functional goals and objectives, while seeking guidance to resolve conflicts

QUALIFICATIONS

• BS in engineering, biological, pharmaceutical, or chemical sciences with generally a minimum of 17+ years of experience inclusive of post graduate education and/or in pharmaceutical or health care industry experience, MS, Ph.D., or Pharm. D. degree preferred.

• Strong people management skills required.

• High-level verbal and written communication skills. Strong attention to detail

• Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to project teams; recognizes global regulatory impact

• Ability to convince stakeholders with facts and data

• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.

• Demonstrates innovative approaches to drive regulatory strategy

• Experience leading interactions with Health Authorities

• Strong knowledge of global HA laws, regulations, guidance, and global regulation submission routes available for new study drugs.

• Ability to succesfully work in ambiguity shaping new quidances on a global level

• Detailed understanding of competitors in the area and what they are doing in early/late development.

• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.

• Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.

High level of integrity and credo-based values

Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job; it is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.