Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe

CSL; Emea; On-site; IDR 2.001.668.000 - 2.502.086.000; Full time

Job summary

A global biotherapeutics leader is seeking a Regulatory Affairs Director in Indonesia. The candidate will develop and execute regulatory strategies, mentor teams, and engage with health authorities to ensure compliance and successful product delivery. Minimum 12 years in the biotech industry and strong leadership skills are required. This role comes with a comprehensive benefits package designed to support employee wellbeing.

Benefits

Health care benefits

Financial protection resources

Support for family needs

Qualifications

• 12+ years in biotech or pharmaceutical industry with 10 years in Regulatory Affairs.
• Experience leading and managing teams for at least 7 years.
• Thorough understanding of regulatory requirements in key regions.

Responsibilities

• Develop global regulatory strategies for assigned product portfolio.
• Lead health authority interactions and drive regulatory outcomes.
• Mentor and coach team members for career growth.

Skills

Strategic thinking

Regulatory knowledge

Team leadership

Effective communication

Relationship building

Education

Bachelor's degree in pharmacy, biology, chemistry, or related field

Advanced degree (MS, PhD, or MBA)

Job description

Description

Summary

• Member of the GRA Global Regulatory Strategy Leads Team (GRSLT)
• Regulatory leaders who develop a global, integrated regulatory strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned portfolio with a strong patient centric-focus, leveraging appropriate business acumen and prudent risk-taking to ensure effective, timely delivery of successful regulatory outcomes from early development through registration and subsequent post‑marketing life‑cycle activities.
• Key member, partner and single GRA representative for the respective Product Strategy Teams (PST) and / or related global R&D / commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ‘One GRA Voice’ and engagement with internal GRAS partners.
• Directly leading health authority interactions in stationed country (FDA or EMA) and building productive relationship and driving positive regulatory outcomes with both FDA & EMA plus global health authorities.
• Leader of a team of Global Regulatory Leads and / or Regional Regulatory Leads at CSL’s global facilities that support life‑cycle management activities or Enabling Healthcare Technologies (EHT). Coaches and ensures effective talent development and career growth of the team.

Main Responsibilities & Accountabilities

• Proactively builds, fosters and promotes effective relationships with GRSLT members to ensure consistency, common approach, and shared learnings amongst department. Actively connects and maintains relationships with GRASLT, GRA Regional LT and Regulatory CMC LT members.
• Proactively contributes and builds effective relationships with respective members of Product Strategy Team (PST), Clinical Development Team (CDT), Safety Management Team (SMT) and / or Device / EHT related development teams, including critical partners, in research, clinical development, commercial development, business development, project management and Global Product Leads (GPLs) ensuring a bi‑directional dialog.
• Engage GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability, ‘team spirit’, and act as regulatory decision maker / approver for GRAST / GRA related project deliverables as needed. Within GRAST, effectively foster two‑way communication between GRAST and R&D teams (e.g. PST), encourage robust regulatory scenario assessment and accountable for delivery of successful regulatory outcomes globally. As needed, lead GRA project deliverables (e.g. Core Briefing Books, GRSO, etc.).
• Accountable for assigned product strategic relationship with key health authorities (FDA & EMA), including CSL contact for home country and for content, plus approach, in all global health authorities. For non‑home country health authority, coaches direct report on effective interaction strategies with respective health authority and as needed, leverages Regulatory TA Head to escalation topics within agencies.
• With direct reports, mentors / coaches team members to develop innovative, courageous solutions to potential challenges, apply enterprise mindset and prudent risk‑taking in strategy development while ensures on‑time execution plus delivery to bring assigned therapies / indications / products to patients. Fosters team development to articulate and communicate with teams / senior leaders the regulatory perspective.
• Single GRA reviewer, and as necessary approver, of deliverables (e.g. protocol, TPP, etc.) generated from PST, CDT, SMT and related delivery teams. In conjunction with Reg TA Head, may participate in regulatory due diligence / divestiture activities for therapeutic area(s) or functional areas. Lead discussion at Global Regulatory Forum (GRF) or with senior management on projects.
• Applies the CSL Leadership Capabilities – Build Bridges, Think Beyond, Unleash Outcomes, Ignite Agility, Inspire the Future and Cultivate Talent – to oneself and mentors team in these capabilities. Ensures succession planning for critical roles and applies servant leadership plus empowerment principles to team members.
• May represent CSL on industry association initiatives / teams, in conjunction with Global Regulatory Science & Policy, and / or as the CSL regulatory representative to Joint Steering Committee (JSC) for CSL partnership(s).

Qualifications & Experience Requirements

• Bachelor’s degree (four‑year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree in a related field (MS, PhD or MD, DVM) or MBA is preferred.
• Minimum of 12 years’ experience in the biotech or pharmaceutical industry, with at least 10 years in Regulatory Affairs.
• Experience in leading and managing teams (Minimum 7 years), setting clear direction, holding people accountable and fostering a collaborative, empowered, learning team environment. Proven ability to make tough decisions.
• Candidates must have thorough knowledge and understanding of pharmaceutical / biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan).
• Experience working in Regulatory Affairs with direct agency interaction responsibility with at least 1 health authority.
• Experience working in a complex and matrix environment is required. Ideal candidates will have a strong clinical or device foundation.
• Strong ethics and integrity.
• Think strategically, takes prudent risks and develops bold, agile, innovative approaches to complex challenges.
• Effective communication skills, with ability to articulate complex concepts in a manner individuals at various levels in the organization can comprehend.
• Builds productive, working relationships within CSL (e.g. R&D and Commercial) and outside the company (e.g. partners, health authorities).
• Fluency in English (verbal and written).

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our to see what’s available to you as a CSL employee.

About CSL Behring

is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, . Our parent company, , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more .

Do work that matters at CSL Behring!