Program Manager - Scientific - Senior True Title: Global Regulatory Project Management and US Support Lead Job Summary
- Responsible for working collaboratively with the Global Regulatory Lead (GRL) and cross functional project teams to ensure global regulatory strategies are developed and seamlessly executed upon, enabling successful filings with Health Authorities.
- Responsible for the planning and execution of high quality regulatory submissions for programs/products of varying complexities, including both pre-approval and postmarketing submissions. Scope includes major global regulatory submissions (NDAs, BLAs, MAAs, INDs, and supplementals) and other US submissions including amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates etc.,) consistent with US regulatory requirements. Responsible for drafting and preparation of forms and cover letters required for US Submissions.
- May with supervision as appropriate, function as main liaison / point of contact between FDA and company.
- Maintain up-to-date knowledge and expertise of FDA regulations/guidance documents, and ICH guidelines.
40% of the time
- Provide project management support for product-specific global regulatory team meetings (GRTs) and cross-functional major submission team meetings to oversee, plan and deliver GRT goals and regulatory submissions.
- Apply established project management practices in support of GRTs and cross-functional major submission teams. This includes preparation of agendas, documentation of decisions, development and active management of timelines, effective issue and risk management.
- Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables. Track Project variances and identify root causes. Conduct lessons learned sessions to identify areas for improvement..
40% of the time
- Responsible for the planning and delivery of US submissions, particlarly those for highly complex programs/products, which will include authoring of certain M1 components where applicable
- Coordinate and consult with GRL and other departments on the content, preparation and assembly of regulatory documentation in support of US filings. Perform final editorial checks of regulatory content prior to hand off to submission management.
- Coordinate and provide operational support for FDA meeting requests, meeting rehearsals, briefing book preparations and assist in the preparation of meeting minutes of FDA meetings.
20% of the time
Education & Qualifications
- Responsible for ensuring regulatory compliance for all assigned responsibilites.
- Act as a conduit of information between assigned cross-functional submission teams and the GRT.
- Work with submission management on the development of regulatory submissions.
- Mentor and train staff within department and assist in providing leadership support to the GRPMUS team.
- Support and contribute to the development, implementation and continuous improvement of PM tools and processes for global regulatory project management of new product licensures and lifecycle project management for existing products.
- BA/B.S in a scientific, healthcare or related field or equivalent experience. Advanced degree preferred, but not required
- 10 or more years of biopharmaceutical experience with emphasis in global regulatory affairs, drug development and project management experience
- Knowledge of FDA regulations and guidelines on drug development and the approval process for NDA/BLA and postmarketing supplements
- Excellent communication skills both written and verbal
- Excellent interpersonal and negotiation skills
- Demonstrates strong ability to collaboratively lead, interact and work effectively with other departments as well as external organizations
- Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple complex projects within assigned timelines
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
- Under supervision of regulatory management and in conjunction with cross-functional team members execute regulatory strategies, develop submission timelines and content plans for both minor and major regulatory submissions of varying compelxity
- Contribute to the development of specific FDA regulatory content supporting company positions as presented in required regulatory documents
- Works on complex problems in which analysis of information requires an in-depth evaluation of various factors
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
- May, with supervision, function as liaison between FDA and company for assigned projects
- Consults with regulatory management and Global Regulatory Leads on product team related issues, planning and submissions
- Co-leads and interacts with cross functional submission team members, e.g. clinical operations, nonclinical, CMC on development timelines and program related issues;
- Works with regulatory operations on the development of regulatory submissions
- 5-10% travel required mostly within North America
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.