Manager Global Regulatory Affairs

Global Regulatory Affairs Manager

Company & Role Description

Founded in 2002, Tanner Pharma Group is a specialty service provider in the biopharmaceutical industry focused on improving patient access to medicines on a global basis. Tanner Pharma offers its biopharmaceutical partners a portfolio of four distinct service offerings that span the product lifecycle from clinical development to commercialization. With its global headquarters in Charlotte, North Carolina and offices in the United Kingdom, Switzerland and Ireland, Tanner Pharma is in a phase of rapid growth.

The Global Regulatory Affairs Manager is responsible for providing regulatory leadership and strategic guidance across Tanner Pharma Group's global portfolio of managed access, expanded access, compassionate use, named patient, post-trial access, and related pharmaceutical access programs.

The role is responsible for evaluating regulatory pathways, supporting program implementation, interacting with health authorities and ethics bodies where appropriate, and ensuring compliance with country-specific regulations governing the supply of unlicensed, investigational, and commercial medicinal products. The Global Regulatory Affairs Manager serves as a key regulatory partner to internal stakeholders, pharmaceutical clients, healthcare providers, and regulatory authorities throughout the product lifecycle.

Familiarity with clinical trial regulatory requirements is beneficial, as the role may occasionally support clinical trial supply activities, protocol-related reviews, and post-trial access planning.

Role Accountabilities

The Global Regulatory Affairs Manager responsibilities include:

Regulatory Strategy and Compliance

• Provide regulatory leadership and guidance for global managed access, expanded access, compassionate use, named patient, market shortage, and post-trial access programs.
• Evaluate and recommend appropriate regulatory pathways for product access across global markets.
• Interpret and communicate country-specific regulations related to the importation, distribution, and supply of medicinal products.
• Maintain knowledge of global regulatory requirements affecting patient access programs, investigational medicinal products, and commercialization activities.
• Support development and maintenance of internal regulatory databases, policies, tools, and standard operating procedures.

Program Regulatory Support

• Review and prepare regulatory applications, dossiers, notifications, and supporting documentation required to establish and maintain access programs.
• Support interactions with health authorities, ethics committees, institutional review boards (IRBs), and other regulatory bodies as required.
• Provide regulatory oversight during program implementation and operational execution.
• Advise cross-functional teams regarding country-specific requirements, timelines, product labeling, importation requirements, and regulatory risks.
• Support regulatory due diligence activities for prospective client opportunities and new program evaluations.
• Support post-trial access planning and, where needed, regulatory activities associated with clinical trial supply.

Cross-Functional Collaboration

• Collaborate with Medical Affairs, Quality Assurance, Pharmacovigilance, Supply Chain, Business Development, Legal, and Program Management teams to ensure compliant program execution.
• Provide regulatory training and guidance to internal personnel.
• Support sponsor communications regarding global regulatory requirements, timelines, risks, and mitigation strategies.
• Build and maintain relationships with regulatory consultants, partners, and external stakeholders worldwide.

Desired Candidate Profile & Capabilities

Required:

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline.
• Advanced degree (MSc, PharmD, PhD, or equivalent) preferred.
• Minimum 5 years of regulatory affairs experience within the pharmaceutical, biotechnology, healthcare, or related industry.
• Demonstrated experience supporting managed access programs, expanded access programs, compassionate use programs, named patient programs, and/or post-trial access programs.
• Experience supporting interactions with regulatory authorities, ethics committees, and institutional review boards.
• Experience in preparing and reviewing regulatory documentation and health authority submissions for managed access, early access and post trial programs.
• Experience with clinical trial regulatory activities (e.g., clinical trial applications, protocol reviews, clinical trial supply) is a plus.
• Global regulatory experience across multiple geographic regions preferred.
• Strong understanding of global pharmaceutical regulatory frameworks.
• Knowledge of regulations governing unlicensed medicines, investigational medicinal products, expanded access, compassionate use, and post-trial supply.
• Familiarity with clinical trial regulatory processes and clinical trial supply requirements a plus.
• Ability to assess complex regulatory requirements and develop practical business-oriented solutions.
• Strong project management, organizational, and communication skills.
• Ability to manage multiple priorities within a fast-paced international environment.
• Strong stakeholder management and cross-functional collaboration skills.

Soft skills:

• Strategic Thinking
• Regulatory Expertise
• Accountability
• Attention to Detail
• Problem Solving
• Collaboration
• Customer Focus
• Continuous Improvement
• Business Acumen

Compensation & Benefits

• Salary commensurate with experience
• Pension scheme (UK)
• Private health insurance.
• Attractive performance incentive plan.
• Vacation, Volunteer and paid sick leave.

Tanner Pharma Group’s Core Values: Everything we do at Tanner Pharma Group is dictated by our values. We take them very seriously, and we are proud of this unwavering commitment.

Check out http://www.tannerpharma.comto view our core values and learn more about our company.

Candidates may be required to organize reference calls upon request. Confidentiality will be respected. Additionally, Pre-employment drug and background screening will be required.

Tanner Pharma Group is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.