Dir/Sr Dir - Global Regulatory Lead

Rhode Island Bar Assn.; United States; Remote; USD 140,000 - 200,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a Director/SR Director Global Regulatory Lead to lead the global regulatory strategy within a Product Development Team. The successful candidate will ensure compliance with regulatory requirements, develop submission plans, and provide strategic input into protocols and regulatory documents. Applicants should possess a solid scientific background and significant experience in regulatory strategy and submission leadership.

Qualifications

• Solid scientific background and understanding of drug development processes.
• Experience leading submission teams and developing regulatory strategies.
• Ability to communicate complex regulatory issues effectively.

Responsibilities

• Lead development of regulatory pathways and plans for product registration.
• Co-lead response teams for health authority queries.
• Establish communication strategies for regulatory issues.

Skills

Interpersonal skills

Leadership

Strategic thinking

Education

Ph.D., M.D., PharmD, MS, or BS with equivalent professional experience

Job description

The Director/ SR Director Global Regulatory Lead (GRL) will have leadership responsibility for global regulatory strategy within a Product Development Team (PDT). They serve as team lead or co-lead of marketing application submission teams for indications that are in late-stage development.

Lead the development of strategy and content for global dossiers.

Develop target labeling and co-lead the cross-functional labeling team. Ensure consistent positions are presented in responses to global health authority (HA) queries.

Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.

In collaboration with the EU regulatory lead, develop global submission plans and HA interaction plans.

Provide input into the development of protocol synopses and protocols.

Co-lead the cross-functional response teams to respond to IND and Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.

Responsibilities:

Participate in Product Development Teams (PDTs). Provide leadership to the PDT on critical project issues.

Lead the development of regulatory pathways and plans for product registration, including associated risk assessments and identification of precedence.

Lead the identification of innovative approaches to resolve complex regulatory issues and increase speed to market.

Lead the content planning for regulatory submissions, strategic documentation and project reviews. Align regulatory plans with commercial and development plans.

Establish one regulatory voice for communication to key stakeholders.

Participate in the development of strategies for product partnering (out-licensing, divestiture, co-development, in-licensing, and acquisitions).

Assure that priority market and non-priority market regulatory issues are addressed in the global development plan.

Assure CMC elements of the overall global regulatory plan are robust.

Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, etc. Review and approve key regulatory documents, including IBs, INDs, IMPDs, CTAs, RMPs, Pediatric Plans etc.

Facilitate identification and internal agreement of optimal product labeling. Provide strategic input on Target Product Profile, CCDS and country-specific labels.

Support effective interactions with HAs globally. Create an asset-specific global HA interaction strategy, integrating regional/local objectives and strategies. Support the preparation of, and participate in/lead (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HAs. Review and approve content of responses to queries from HAs for respective regions/countries.

Drive the creation and execution of the global submission plan. Formulate integrated global submission plan for simultaneous filings and communicate rationale for deviation from simultaneous submissions.

Apply to: [e-mail]

Apply to: [e-mail]

Requirements – Education and Experience

Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with equivalent professional experience.

Understanding of medical and scientific content and associated complexities.

Significant knowledge of the drug development process is required.

Understanding of strategic and tactical role and deliverables of regulatory strategy in the product development and commercialization process.

Understanding of policy, laws, regulations and guidelines as they apply to HAs globally for drug development and approval.

Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.

Experience in successfully leading submission teams.

Direct experience in developing strategy and leading teams through interactions with health authorities.

Track record of resolving issues with HAs.

Experience in developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.

Experience in communicating the regulatory strategy, issues, and risks in written and verbal format to management and other governing bodies.

Ability to broadly represent department functions on project team in a matrix organization.

Demonstrated ability to coordinate global activities, drive quality decision-making, organize/prioritize tasks, negotiate with and influence others, and facilitate issue resolution and conflict management.

Apply to: [e-mail]