Global Regulatory Affairs Manager

Global Regulatory Affairs Manager – Managed Access Programs

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 Brazil, Tanner Pharma is in a phase of rapid growth.

We are looking for a regulatory affairs specialist to join our team and provide the oversight for our Managed Access Programs (MAP) division and be the internal expert for all regulatory requirements. You have the opportunity to join a dynamic, growing company in the MAP space, making a difference in patients’ lives.

Role Accountabilities

Expected Responsibilities for the Global Regulatory Affairs Manager are:

• Develop and execute the global regulatory strategy for MAPs in collaboration with internal and external stakeholders.
• Provide regulatory support to the Business Development, Program Management and Customer Service teams.
• Participate in the review of new project proposals and bid defence documentation to ensure alignment with global regulatory requirements.
• Participate in meetings with prospective clients to present Tanner’s service offering and capabilities.
• Ensure compliance with all relevant regulations, guidelines, and ethical standards for MAPs in different countries and regions.
• Manage the submission and approval process for MAPs with health authorities and ethics committees.
• Maintain a database of the regulatory requirements, landscape, and best practices for MAPs in each relevant country for matters such as program setup and operational requirements, product labeling, real-world data collection, and pharmacovigilance.
• Communicate and liaise with regulatory agencies as needed to support the setup of MAPs.
• Create country summaries, carrying out country-specific research as needed.
• Keep abreast of regulatory changes towards the procurement, movement, and distribution of unlicensed medicines.
• Manage and expand a network of local regulatory advisory firms.
• Build out and manage a team of regulatory experts as the company expands.

Desired Candidate Profile & Capabilities

Required:

• A bachelor’s degree or higher in life sciences, pharmacy, or a related field.
• At least 5 years of experience in regulatory affairs in MAPs or pre-approval access programs.
• A thorough understanding of the specific regulatory requirements and processes for MAPs in different countries and regions.
• Experience working with US Expanded Access and group programs in France, Italy, Germany, Spain, the UK, and Belgium.
• Strong project management and problem-solving skills.
• The ability to work independently and collaboratively in a fast-paced environment.
• A dynamic, flexible and problem solving attitude.

Soft skills:

• Communication: Able to communicate in a clear, appropriate, effective and efficient manner in various situations (1:1 or group settings, verbal & written)
• Problem-solving: Able to handle difficult or unexpected situations in the workplace as well as complex business challenges
• Project Management: Able to effectively coordinate a project from start to finish; using effective communication, interpersonal skills, and organization to complete projects within defined parameters and timelines.
• Team Member: Ability to integrate with the organizational Core Values, culture, and team climate. Works well with a team to achieve a common goal.

Compensation & Benefits

• Salary commensurate with experience
• Pension scheme (UK)
• Private health insurance
• Attractive performance incentive plan
• Vacation, Volunteer and paid sick leave
• Salary: £70,000-£80,000 per year

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’re proud of this unwavering commitment.

Check out www.tannerpharma.com to 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.

Job Type: Full-time

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