Senior Director, Global Regulatory Portfolio Lead

15+ years

Not Disclosed

Princeton Junction

10 Nov. 28, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Director, Global Regulatory Portfolio Leader
Location: East Coast, with intermittent travel to New Jersey (Princeton)
Company: Sun Pharmaceutical Industries Ltd.

Position Overview

The Senior Director, Global Regulatory Portfolio Leader will lead the regulatory strategy for in-line and pipeline assets in one or more therapeutic areas. The role will focus on ensuring efficient global registration pathways for regulatory approval and maintaining or expanding product licenses across geographies. This role will report directly to the VP/Head, Global Regulatory Affairs (GRA) and may serve as a US agent for one or more assets. It will be an integral part of the Global Regulatory Affairs Leadership Team.

Key Responsibilities

Leadership & Strategic Guidance

Serve as the key corporate regulatory contact for US and other markets as applicable. Potentially serve as US Agent for assigned assets.
Manage a team of US and/or global regulatory leaders, providing strategic and operational direction.
Develop and execute regulatory commitments for assigned programs, ensuring compliance with regulatory guidelines.
Guide the pipeline’s progression by ensuring adherence to regulatory milestones.

Regulatory Strategy & Execution

Stay updated on regulatory agency regulations, directives, and policies that could impact product development.
Lead communications with regulatory agencies (FDA, EMA, etc.) and ensure all interactions are in compliance with established procedures.
Facilitate the development and submission of regulatory filings for in-line and pipeline products.
Ensure documentation of all regulatory communication is maintained and distributed to relevant teams.
Monitor timelines for submissions and regulatory milestones, ensuring alignment with internal teams.
Oversee the development of regulatory sections in product submissions.

External Relationships & Training

Build and nurture relationships with regulatory agencies, industry groups, and business partners.
Lead and support regulatory agency inspections and audits.
Conduct training for regulatory strategists and other teams on regulatory policies and procedures.
Contribute to the development and review of departmental procedures.

Qualifications

Experience & Education

15+ years of global regulatory experience, with proven leadership in regulatory strategy, achieving regulatory approvals, and health authority engagements (e.g., FDA, EMA).
Experience in leading and developing teams, managing resource allocation, and overseeing workload prioritization.
In-depth knowledge across regulatory disciplines (e.g., global/regional strategy, clinical, CMC).
Direct experience in authoring and filing regulatory documents in major regulated markets.
Advanced degree (MD, PhD, PharmD, JD, MS, MBA) preferred.

Skills & Abilities

Strong leadership and team-building skills, with the ability to coach, develop, and delegate tasks.
Demonstrated strategic thinking and ability to influence regulatory submissions and approvals.
Expertise in regulatory documentation and submission processes.
Excellent communication and interpersonal skills for liaising with regulatory bodies and internal teams.

Benefits & Compensation

Participation in the Annual Performance Bonus Plan and eligibility for Long-Term Incentive Plan.
Full employee benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, and 401(k) plan.
Paid time off (vacation and sick days), employee assistance programs, and other company benefits.

How to Apply

Candidates interested in applying should do so directly to Sun Pharmaceutical Industries Ltd.

Sun Pharmaceuticals is an equal opportunity employer, committed to diversity and inclusion. We do not discriminate based on race, religion, gender, or any other protected characteristic.

Please note, Sun Pharmaceuticals is not accepting unsolicited resumes from agencies or search firms for this job posting.

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