Kerja Sepenuh Masa, (Associate) Director, Regulatory Affairs di Everest Medicines - Maukerja

Job Purpose

Provide strategic regulatory leadership for the company's local and Asia-Pacific (AP) portfolio, shaping and executing regulatory strategies that accelerate product registration, protect market access and support the full product lifecycle, from development through post-approval. Lead and develop a small regulatory affairs team, act as the senior regulatory voice to executive leadership and cross-functional partners, and represent the company with health authorities, ensuring all regulatory activities are compliant, high quality and aligned with business objectives, including BD and M&A priorities.

Key Responsibilities

Regulatory strategy

• Define and own regulatory strategies for assigned products and therapeutic areas to support product registration, MAT, M&A due diligence and lifecycle management, balancing speed to approval, risk and commercial value.
• Provide regulatory input into BD assessments and due diligence, including evaluation of regulatory pathways, timelines, data gaps and risks for in-licensing and acquisition opportunities.
• Identify, assess and mitigate regulatory risks, and proactively identify opportunities (e.g. expedited or priority pathways, reliance on prior approvals) to facilitate business growth.
• Ensure alignment of regulatory strategies with local regulatory requirements and business goals, and contribute to regional/global regulatory strategy and portfolio planning.
• Provide regulatory insights and recommendations to senior management and governance forums to support timely, well-informed decision-making.
• Monitor changes in regulatory policies and guidelines, assess their impact on the portfolio, and communicate implications and action plans to relevant stakeholders.

Registration, submission and compliance

• Oversee and/or perform preparation, submission, and maintenance of regulatory filings and submissions to health authorities.
• Set priorities and timelines for the submission portfolio; ensure submissions are high quality, on time and well coordinated, and that health authority queries are answered effectively.
• Ensure compliance with local and regional regulatory requirements, including post-approval commitments, variations, licence renewals and labelling updates.
• Ensure inspection and audit readiness of regulatory processes and records, and adherence to company SOPs and quality standards.

Regulatory affairs management

• Coordinate and oversee regulatory activities across multiple projects and therapeutic areas, ensuring resources and priorities are aligned with business needs.
• Represent the company in meetings and communications with regulatory agencies (e.g. pre-submission and scientific advice meetings), and build constructive, long-term relationships with regulators.
• Represent the company in industry associations and external forums where appropriate and contribute to shaping the regulatory environment.
• Manage the regulatory budget and external vendors, consultants and service providers, as applicable.

Cross-functional collaborations

• Work closely with Supply, Artwork Centre, Clinical, Quality, Manufacturing/PD, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Provide regulatory expertise and support to cross-functional project teams.
• Facilitate effective communication and collaboration between regulatory affairs and other departments.

Documentation and reporting

• Maintain accurate and comprehensive regulatory documentation and records.
• Establish and continuously improve regulatory processes, SOPs, tracking tools and KPIs (e.g. submission timelines, approval status) to drive efficiency and compliance.
• Prepare and present regulatory reports, summaries, and updates to senior management and other stakeholders.

Leadership

• Lead, coach and develop a small team of regulatory affairs professionals
• Allocate resources and prioritise workload across the team to deliver departmental objectives on time, within budget and to a high standard of quality.
• Lead organisational change and process improvement initiatives within the function.

Qualification & Experience

• Bachelor's degree or above in pharmacy, life sciences or a related scientific discipline; advanced degree (Master's, PhD, PharmD or MBA) preferred.
• Minimum 10 years of regulatory affairs experience in the pharmaceutical including regulatory strategy and submissions leadership.
• Strong knowledge of local and AP regulatory requirements and guidelines, with a track record of successful registrations and lifecycle management.
• Demonstrated leadership and people management skills
• Excellent strategic thinking and problem-solving abilities, with sound judgement in ambiguous situations.
• Effective communication, influencing and interpersonal abilities, including with senior management and external stakeholders.
• Strong organizational and project management skills, with the ability to prioritise across multiple projects.
• Ability to work effectively in a fast-paced, dynamic environment.