The Senior Regulatory Affairs Project Manager (Sr. RA PM) develops and delivers innovative, breakthrough global regulatory strategies for all products in development. The Senior RA PM is responsible for regulatory aspects related to product development and approval in alignment with the global business strategy and in partnership with the functional subject matter experts within the Prescription Strategic Innovation Group.
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
BSc, MSc, PhD, PharmD in scientific discipline
Minimum of 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
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
Experience with managing service providers
Internal Number: 0001234
About GALDERMA LABORATORIES L.P.
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin.
For more information, please visit www.galderma.com/us.