Director, Regulatory Affairs

1 Job Overview

The Director, Regulatory Affairs is responsible for developing and implementing regulatory strategies, ensuring alignment with Sr. Management to secure and maintain approval/s for the assigned country and / or region from clinical development through to product approval and commercialization. Deep expertise with agency interactions and a strong track record of delivering regulatory success for innovative therapies. Comfortable executing and authoring key regulatory sections, if required, to get the work done in a fast-moving environment. At the intersection of science, clinical development, and regulatory execution, bringing a pragmatic, solutions-oriented mindset to navigating complex regulatory pathways, including those relevant to rare diseases and accelerated development.

Enable patient access via successful contribution to the registration and maintenance of Orphalan's products whilst ensuring regulatory compliance, under the oversight of the Global Head of Regulatory Affairs, collaborating with cross-functional teams to support Orphalan's growth.

2 Key Responsibilities and Duties

Main Role and Responsibilities include:

• Lead the development and implementation of global regulatory strategies for assigned portfolios or therapeutic areas, ensuring alignment with organizational goals and regulatory requirements.
• Provide expert regulatory strategic direction throughout the product lifecycle, from pre-approval through post-marketing activities, to support successful registrations and lifecycle management in accordance with corporate objectives.
• Lead the preparation for regulatory agency meetings, direct submission strategies, and coordinate the development and author (if required) key regulatory documents for submissions such as for ODD, scientific advice and marketing authorization (MA)
• Serve as the primary contact for health authorities and manage interactions with internal and external stakeholders as needed.
• Support the regulatory information management (RIM) lead with the management of the regulatory database and archiving of MA dossiers and regulatory information into Veeva RIM.
• Contribute regulatory expertise to internal governance and advisory committees, addressing strategic, operational, and procedural regulatory matters.
• Collaborate closely with senior leadership and cross-functional teams, including Clinical, Commercial, and Medical Affairs-to provide regulatory insights and inform broader drug development strategy.
• Maintain up-to-date knowledge of evolving regulatory landscapes, contribute to policy development, and support regulatory intelligence initiatives leveraging internal expertise.
• Exemplify high standards of ethical conduct, leadership, and transparency in all interactions with internal teams, health authorities, and external partners.
• Demonstrates expert knowledge of applicable GxPs and excels at identifying, sourcing, and interpreting complex regulatory requirements to ensure organizational compliance and informed decision-making

3 Required Skills and Experience

• Significant experience (10+ years) in regulatory affairs in pharmaceutical regulatory affairs, including a proven track record of successful hands on submissions and interactions with health authorities.
• In-depth experience of drug development, new drug applications, post marketing maintenance, and complying with regulatory requirements. Proven ability to apply scientific and business judgment to regulatory decision making.
• Documented achievements in obtaining product registrations and managing regulatory activities throughout various stages of development and commercialization with major agencies such as the FDA, EMA, MHRA, NMPA, HC, TGA, PMDA.
• Experience and understanding of eCTD - preparation of the submission content plan for major eCTD filings such as the IND/BLA/NDA/MAA. and global procedure types (CP, MRP, DCP, NP, NDA, IND, CTA, BLA).
• Skilled at handling complex regulatory challenges and managing multiple projects simultaneously under tight deadlines.
• Strong ability to foster relationships and collaborate effectively with internal, external stakeholders, and senior management across all organizational levels.
• Exceptional interpersonal abilities and proficiency in both written and verbal communication, tailored to local regulatory environments.
• Demonstrated expertise in identifying, assessing, and mitigating regulatory risks.
• Advanced knowledge of emerging regulations and guidance, including proficiency in relevant GxPs and the capability to source, interpret, and apply regulatory information to local, regional and business requirements.
• Ability to manage and deliver projects and programs on time.
• Excellent verbal and written communication and presentation skills, with fluency in English; other languages advantageous

4 Desired Skills and experience

• Medical devices experience is beneficial
• Rare disease, Cell and Gene Therapy, diverse therapeutic experience
• Strong consulting acumen with the ability to influence and guide cross-functional teams
• Leadership, strategic vision and negotiation skills

5 Education and Qualifications

• Minimum of a Bachelor's degree in the life sciences

Relevant advanced degree to PhD, is preferred