The position is based in Lausanne area, Switzerland and is reporting to the Head of RA Project Management.
Develops and delivers global regulatory strategies for development products.
Execution of regulatory aspects related to product development and approval.
Primary RA contact for assigned Rx products.
Key deliveries & accountabilities:
Develops and executes Regulatory Strategies for development products
Develops and maintains a global regulatory strategy plan; assures relevant input is vetted and included in the development strategy in order to deliver on the Target Product Profile, regional specific needs, regulatory environment, regulatory risks and mitigations; and global submission strategies.
Develops regulatory strategic leadership for product development projects including health authority interactions (e.g. EMA, FDA), regulatory submissions (e.g. IND, CTA, MAA, BLA, NDA) and other regulatory requirements in line with corporate objectives, timelines and budgets.
Identifies and assess risks associated with product development and recommend strategies to mitigate these risks.
Ensures strategic regulatory input is provided to key development activities and documents, including clinical protocols, clinical and non-clinical reports and summary documents, statistical analysis plans, etc.
Executes Regulatory Project Management activities
Develops regulatory tactical leadership for product development projects including health authority interactions (e.g. EMA, FDA), regulatory submissions (e.g. IND, CTA, MAA, BLA, NDA) and other regulatory requirements in line with corporate objectives, timelines and budgets.
Provides leadership and direction with regards to necessary health authority interactions.
Ensures timely execution of regulatory deliverables.
Communicates project updates and risks to RA PM Leadership, Program Directors, and other stakeholders across the organization.
Participates and provides regulatory perspective on product development project teams as needed.
Participates on product development project teams, as needed.
Assists in developing regulatory presentations to product development project teams and pipeline council as appropriate.
Builds and manages relationships with business partners (both internal and external).
Acts as member of Regulatory Affairs Project Management Team
Represents RA PM function on project teams.
Ensures collaboration with key internal stakeholders of the Global RA department.
Participates in due diligence activities as needed.
Manages the quality system aspects for RA PM function
Develops/maintains standard operating procedures and work practices for RA PM team.
Anticipates improvements to processes to ensure continued compliance with applicable regulations.
10 years of experience in the Pharmaceutical/Biotech industry, including at least 5 years of experience in direct drug/biologic development with IND, NDA, CTA, MAA or BLA filing experience.
Experience with managing service providers.
Experience with systemic drugs (Small Molecules and Biologics).
Experience of project management in an International environment.
Required Skills and Knowledge:
BSc, MSc, PhD in scientific discipline or Pharmacist.
Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, and EU).
Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
Experience interfacing with regulatory agencies and skill at developing and implementing successful global regulatory strategies.
Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
Excellent team interaction skills along with demonstrated ability to work on a cross-functional team.