US Regulatory Lead, Biosimilars - Remote
- Region: US
- Department: Regulatory
About this role:
As the Associate Director, US Regulatory Biosimilars, you will be responsible for developing and delivering innovative regulatory strategies for Biosimilar product development, approval, and Life-Cycle Management activities for assigned assets in the US, in alignment with the global business strategy. You will be responsible for contributing to the Global Regulatory Plan and strategy for the US territory and accounting for the requirements of the FDA and other regulatory bodies. You will also be responsible for leading the regulatory activities for the development, registration, and Life-Cycle Management of Biosimilar asset(s) in the US, across multiple indications and/or development stages and for ensuring compliance. You represent the company with domestic regulatory authorities, contractors, and corporate partners along with the management of outsourcing and vendor management for in-country Regulatory Affairs execution where needed. You will lead and oversee the Biosimilar regulatory policy, coordinating and providing input from Biosimilars Business Unit in partnership with internal policy teams. There will also be coordination and oversight of Biosimilar regulatory Ad/Promo activities in close partnership with internal Ad/Promo teams. You will also be working across various project teams, workstreams, functions, partners, and committees and steering and supporting regulatory team members and/or direct reports.
What You’ll Do:
· You are responsible for directing US regulatory strategies for inclusion in the Global Regulatory Plan, on assigned projects and programs and for securing and alignment on those strategies with the GRL and other key stakeholders.
· You are a key contributor to the development and maintenance of pre-clinical, and both early and late-stage clinical development plans, defining and aligning US strategic considerations with the Global Regulatory Lead and project team.
· Provide leadership on project teams and subcommittees in all areas of US regulatory affairs and product development.
· Set US strategic direction and lead US regulatory submission process with submission teams, including marketing applications and core briefing packages.
· Responsible for ensuring the implementation of defined US regulatory strategies, directing organisation and preparation of clear and effective US submissions, across all stages of a products life from development through LCM.
· Identify and assess US regulatory risks associated with product development and working with GRL define strategies to mitigate risks identified.
· Direct and oversee US regulatory labelling requirements taking into account reference product, safety, commercial and medical drivers and oversee the implementation to ensure successful execution.
· Oversee the initial set up and management of biosimilar regulatory Ad/Prom vendor for US, partnering closely with internal Ad/Prom teams, to ensure consistent one Biogen approach. Providing vendor oversight on deliverables.
· Monitor and analyse US regulatory policy agenda, with presence on external regulatory committees/trade associations.
· Assess impact of external draft policy on Biogen Biosimilars, co-ordinate input from key stakeholders on regulatory policy agenda for change, and partner closely with internal policy teams to ensure one Biogen voice.
· Oversee the set up and management of vendors supporting US regulatory activities, building strong relationships to ensure successful and timely execution of the regulatory deliverables in line with US requirements.
· 8 years pharmaceutical/biotechnology industry experience with technical management.
· A minimum of 6 years in US/ Global Regulatory Affairs (Strategy).
· Experience working regulatory aspects of products in pre-clinical and clinical development.
· Late-stage development regulatory experience, including leading a significant submission (ex: NDA or BLA).
· Direct experience in interfacing with FDA and ability to foster effective, positive interactions with regulatory agencies, and corporate partners.
· Good knowledge of applicable regulations and experience in interpretation of regulations, guidelines, policy statements, etc.
· Experience and knowledge in the preparation of major US regulatory submissions and supportive amendments or supplements.
Who You Are:
In addition to having exceptional relationship building with the agencies, you successfully worked in a matrix environment where you collaborated with other teams within the organization. You have strong US Regulatory experience along with strong teamwork capabilities.