Senior Manager – Regional Head, Regulatory APAC

This is a fully remote position, open to applicants in Philippines.

📋 Description

• Deliver strategic regulatory consulting and leadership across intricate global, regional, and local regulatory programs.

• Facilitate high-quality client service delivery that aligns with business goals.

• Assist in regional workforce planning, resource visibility, and capacity discussions with the Global organization.

• Foster growth through client development, cross-selling, proposal management, and business development initiatives.

• Support Practice Area strategies, objectives, and annual business plans.

• Contribute to regional operational efficiency, resource planning, utilization transparency, capability development, and escalation of personnel or capacity risks.

• Enhance financial performance through resource planning, budget oversight, and operational management.

• Identify opportunities for innovation, efficiency enhancements, and service expansion.

• Provide adaptable Regulatory Affairs services, strategic insights, and hands-on assistance in preparing and submitting documentation.

• Oversee team capability, availability, development needs, and regulatory delivery readiness at the regional level.

• Participate in and lead regulatory processes to acquire and maintain marketing authorizations for human and veterinary medicinal products, medical devices, cosmetics, food supplements, and herbal products.

• Prepare, review, and compile regulatory affairs project documentation.

• Communicate with clients and Health Authorities effectively.

• Lead scientific advice procedures.

• Offer regional line-management leadership for designated regulatory professionals.

• Lead, manage, and develop regulatory professionals while nurturing an inclusive, collaborative, and high-performing culture.

• Provide guidance, coaching, mentorship, and feedback to promote professional development.

• Conduct performance evaluations and development discussions, supporting career advancement plans.

• Advise on employee capabilities, development needs, availability, and suitability during staffing discussions.

• Identify talent gaps and implement focused development initiatives.

• Assist in recruitment, workforce planning, interviewing, onboarding, and integration of new staff.

• Drive technical regulatory expertise, knowledge sharing, training, and dissemination of regulatory intelligence.

• Establish and uphold best practices, standards, and consistent operational methods.

• Encourage the development of future subject matter experts and leaders.

• Advocate for innovation and the adoption of new tools, technologies, and methodologies.

⛳️ Requirements

• Extensive professional experience in the pharmaceutical, biotechnology, or related healthcare industries.

• Strong network within the industry and associations.

• Solid understanding of market trends in the pharmaceutical industry relevant to one’s technical expertise.

• Complementary knowledge and skills, including financial and business acumen.

• Proven experience in leading, developing, and retaining diverse teams.

• Experience in coaching and mentoring employees across various levels of seniority.

• Strong grasp of organizational development, workforce planning, and talent management principles.

• University degree in Life Sciences.

• Strong coaching and mentoring abilities.

• Capability to build trust, promote psychological safety, and foster an inclusive workplace culture.

• Experience in managing organizational change and guiding teams through transformation.

• Ability to lead, mentor, manage, and inspire staff.

• Proficiency in leading large international and/or complex project teams.

• Capacity to balance client requests with company interests.

• Ability to quickly adapt to new, unknown, and challenging situations.

• Experience in business process reengineering and change management consultation.

• Ability to manage client relationships at all levels, including C-suite executives.

• Excellent written and verbal communication and negotiation skills.

• Business fluency in English; additional language skills are appreciated.

• Bachelor’s degree in business administration, healthcare management, or a related field, or equivalent experience required.

• Master’s degree in business administration, healthcare management, or a related field, or equivalent experience preferred.

• Over 10 years of experience in Regulatory Affairs within the pharmaceutical/healthcare industry.

• At least 5 years of experience in a management role required.

• Certification in clinical research or regulatory affairs preferred.

• Certification in health economics, outcomes research, or real-world evidence methodologies preferred.

🏝️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned with local market practices.

• Equal employment opportunity and non-discriminatory practices in recruiting, training, compensation, benefits, promotions, and transfers.

• Reasonable accommodations during the employment process for individuals with disabilities.