Director, Regulatory Affairs, Ex-US

Larimar Therapeutics; Philadelphia (Philadelphia County); Vor Ort; USD 180.000 - 280.000; Vollzeit

Zusammenfassung

Larimar Therapeutics, Inc. seeks a Director, Regulatory Affairs, Ex-US to shape global regulatory strategy for products in development across Europe and other regions.

You will lead submissions, provide tactical guidance to cross-functional teams, and ensure alignment with Larimar's global regulatory plan. The role reports to the Regulatory Affairs Senior Director and collaborates with Commercial, Medical, Legal and Compliance to prepare advertising materials and regulatory submissions while

Qualifikationen

• Minimum of 4-year undergraduate degree.
• 5 to 8 years experience in Regulatory Affairs in the pharmaceutical industry; EMA, MHRA experience preferred.
• Understanding of GxP systems and quality principles.
• Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to aid in global regulatory strategies.
• Experience with preparation of documents for global Health Authority submissions including IND amendments, CTA submissions, and global marketing authorization packages.
• Excellent communication, time management and project management skills.
• Continuous quality improvement mindset and attention to detail.
• Can-do attitude, flexibility and mental agility.

Aufgaben

• Lead strategies to maximize global regulatory success towards program objectives for complex development projects.
• Provide tactical advice to project teams and stakeholders to achieve timely submissions and approvals while ensuring compliance.
• Lead regulatory submissions to ex-US health authorities to align with Larimar’s regulatory strategy.
• Collaborate with Commercial, Medical, Legal, Compliance on advertising and promotional materials and OPDP submissions.
• Prepare Larimar regulatory impact assessments of global guidance, initiatives, and advisory committee activities.
• Develop internal regulatory procedures and practices.
• Work closely with RA Sr. Director and serve as backup to other global region regulatory activity.

Kenntnisse

Regulatory affairs

EMA familiarity

Global regulatory strategy

IND submissions

Communication

Project management

GxP knowledge

Ausbildung

Bachelor's degree

Jobbeschreibung

Director, Regulatory Affairs, Ex-US

Larimar Therapeutics Philadelphia, Pennsylvania, United States

About this position

Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich’s ataxia. Friedreich’s ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to genetic abnormality.

The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

If you are searching for a company where urgency, agility, and commitment to science win the day – we welcome you!

Position Summary:

Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions. The Regulatory Affairs Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director.

Job Duties/Responsibilities:

• The Director of Regulatory Affairs ex-US will be a key member of project teams to define, develop and lead strategies to maximize global regulatory success towards achievement of program objectives for complex development projects
• Provide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements
• Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar’s global regulatory strategy and plan
• Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions
• Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings
• Develop internal regulatory procedures and practices
• Work closely with RA Sr. Director and serve as backup to other global region regulatory activity

Requirements:

Key Experience, Skills and Knowledge:

• Minimum of 4-year undergraduate degree
• 5 to 8 years’ experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred
• Understanding of GxP systems and Quality principles
• Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies
• Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications
• Excellent communication, time management and project management skills
• Continuous quality improvement mindset and attention to details
• Can do attitude, flexibility, and mental agility

Equal Opportunity Employment

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.