Director (Principal Scientist), Regulatory Liaison - Oncology

Merck & Co.; Rahway (NJ); On-site; USD 180,000 - 260,000; Full time

Job summary

Merck & Co. seeks a Global Regulatory Liaison to drive worldwide regulatory strategy for Oncology, Immunology, and Devices projects.

You will oversee regulatory plans, coordinate with Product Development Teams, and act as single point of contact for assigned products throughout development and lifecycle. You will interact with global agencies (FDA/EMA) and subsidiaries, lead submissions, and guide teams to achieve timely market authorizations.

Qualifications

• Bachelor’s degree with 10+ years of drug development or regulatory experience.
• MS/Regulatory or Pharmacology degree with 10+ years of experience.
• PhD with relevant regulatory experience.
• MD with 5+ years regulatory or clinical experience.

Responsibilities

• Develop worldwide regulatory strategy to optimize label and shorten time to approval.
• Lead cross-functional regulatory team coordinating support for development programs.
• Represent company with FDA, EMA; chair meetings with health authorities.
• Review and approve worldwide regulatory submissions, protocols, and documents.
• Coordinate regulatory activities across regions to support global registration plans.

Skills

Strategic thinking

Regulatory submissions

FDA/EMA experience

Project leadership

Communication skills

Education

Bachelor's degree in biological science

Master's degree in regulatory/Pharmacology

PhD in a related discipline

MD with relevant experience

Job description

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.-

The Global Regulatory Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the Oncology, Immunology and Devices therapeutic area.--

The candidate will be a self-starter and provide regulatory oversight for assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects, functioning as the single, accountable, global point of contact on those projects.--

Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our Company's investigational and marketed drugs/biologics. Programs may be complex with more than one indication, formulation or have an external business partner.--

Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation.--

Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Primary activities include, but are not limited to:

Primary Responsibilities

• Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
• Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
• Provide direction- to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
• Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
• Represents our Company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our Company's teams for meetings with FDA at any phase of drug development.
• Lead cross-functional efforts to prepare for advisory committees.
• Coordinate interactions with foreign agencies through Regulatory Affairs Europe (RAE) and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
• Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release from our Company to external stakeholders.
• Represent GRA within our Company's internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Development Team (EDT), and labeling teams (LEAD).
• Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
• Participate in regulatory due diligence activities for licensing candidate review.

Education Minimum Requirements

• B.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinical experience or regulatory affairs.
• M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs.
• PhD with minimum of 7 years relevant experience.
• M.D. with minimum of 5 years relevant experience.

Required Experience and Skills

• Ability to achieve optimal results with limited day-to-day direction.
• Ability to think strategically and continuously learn and apply new knowledge.
• Ability to lead, influence, and negotiate.
• Led or directly supported meetings with FDA, EMA, or other Health Authorities.
• Led or directly supported regulatory filings.
• Proactive, clear and effective verbal and written communicator.

Preferred Experience and Skills

• Oncology experience.
• Immunology and biologics experience.
• Substantial experience in regulatory affairs in at least one major country/region (e.g., U.S.A., European Union, Japan, China).

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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