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Regulatory Associate Director
1 month ago
Job Title: Regulatory Affairs Manager III
Location: 100% Remote
Duration: 12+ Months with possible extension
The US Regulatory Associate Director will be responsible for developing and delivering innovative regulatory strategies for Biosimilar product development, approval, and LCM activities for assigned assets in the US, in alignment with the global business strategy. 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. 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. Represent the company with domestic regulatory authorities, contractors, and corporate partners. Management of outsourcing and vendor management for in-country RA execution where needed. Lead and oversee Biosimilar regulatory policy, co-ordinating and providing input from BBU in partnership with internal policy teams. Co-ordination and oversight of Biosimilar regulatory Ad/Prom activities in close partnership with internal Ad/Prom teams. Working across various project teams, workstreams, functions, partners, and committees. Steering and supporting regulatory team members and/or direct reports (as applicable)
• Responsible for directing US regulatory strategies for inclusion in the GRP, on assigned projects and programs and for securing and alignment on those strategies with the GRL and other key stakeholders.
• 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 organization 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 management of biosimilar regulatory Ad/Prom vendor for US, partnering closely with internal Ad/Prom teams, to ensure consistent one *** approach. Providing vendor oversight on deliverables.
• Monitor and analyze US regulatory policy agenda, with presence on external regulatory committees/trade associations.
• Assess impact of external draft policy on *** Biosimilars, co-ordinate input from key stakeholders on regulatory policy agenda for change, and partner closely with internal policy teams to ensure one *** voice.
• Foster and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
• 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.
• Mentor and guide team members and/or direct reports in carrying out responsibilities.
• Responsible for defining goals, and career development of direct reports (where applicable).
• Provide input to Regulatory Senior Management teams.
• Prepare and deliver effective presentations for internal and external audience.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
