Regulatory Affairs Strategist (Remote Position)

Job Title: Regulatory Affairs Strategist

Location – US (Remote opportunity)

Navitas Life Sciences is pursuing an aggressive growth plan to leverage consulting, industry insights, deep domain and operations expertise to deliver FSP services and in Regulatory, Safety and Technology, as well as E2E Clinical Services as a global CRO. The Navitas Life Sciences Consulting practice is in a rapid growth mode and looking for multiple consultants across levels to meet these growth needs.

Position Summary: Navitas Life Sciences is looking for an experienced Regulatory Affairs Strategist with extensive working experience in a regulatory environment with effective project management skills and in getting fast approvals and has ability to work with internal & external teams to evolve submission strategies.

Responsibilities Includes but not limited to:

· Regulatory Strategy and Plan for investigational and commercial products, in line with ICH requirements, regional requirements and responsible for original INDs/CTAs and NDAs/MAAs for assigned territories

· Design and execute, efficient and effective regulatory strategies for Oncology programs, such as Post Marketing Requirements (PMR), line extension developments, etc.

· Supporting global regulatory filings and assessments as required by the individual project

· Driving risk assessments, identified Regulatory compliance and cGMP needs, implemented action plans

· Author briefing book for agency meetings (e.g., pre-IND, EOP-2, pre-NDA and other meetings as required).

· Author BLA/NDA and other applications for submission, as required.

· Participate and negotiate cost effective development programs and labeling discussions with the FDA, as required.

· Support global regulatory filings and assessments as required by the individual project.

· Co-ordinate and work closely with Company’s Clinical SME, CMO, Medical Affairs, CRO, R&D Teams and internal/external stakeholders for strategy formulation.

· Provide regulatory due diligence support as required

Minimum Required Education and Experience:

· Strong communication, 10 to 15 years’ experience working in a regulatory environment with effective project management skills

· Strong experience in getting fast approvals and has ability to work with internal & external teams to evolve submission strategies.

· Should have 3 to 5 product approvals (NDA) and several IND approvals to his credit

· Strong Experience in Regulatory strategy in particular with oncology, Process and Change Management, KPIs and Metrics, Project Management

· Experienced in HA liaison and seeking HA approval for products in US, EU and ROW markets

· Knowledge of Global submission standards (FDA, HC, EMA, ICH etc.), and industry trends for dossier preparation (i.e. IND/CTA/NDA/MAA/NDA) and Regulatory Operations

· Able to coordinate with client and internal operational teams across the globe on the needs

· Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information, as necessary

· Sound understanding of information management concepts and tools needed to perform regulatory operations priorities in support of all business areas

Mandatory Skills:

· FDA Interaction and negotiation

· Industry trends for dossier preparation (i.e., IND/CTA/NDA/MAA/NDA) and IND approvals