Director, Regulatory Affairs CMC

About the company

The company Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At the company, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. The company’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

The company’s team is inspired to touch and help change lives through the company’s clinical studies in the field of oncology. The company has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

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HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

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HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

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HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

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HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). The company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role

The Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high-quality global regulatory filings. This role will provide regulatory strategy input and oversee preparation of regulatory submissions in collaboration with other stakeholders including CMC, Supply Chain and QA. The Director is responsible for providing regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders. This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide strategic and operational management of preparation and maintenance of CMC regulatory filings to support ongoing clinical activities as well as marketing applications.

Role and Responsibilities

• Develop and execute CMC regulatory strategies for Clinical Phase and Commercial Development as life cycle management.

• Manages the preparation of high quality Regulatory CMC submissions including, IND, IMPD, BLA, MAA and post approval supplements as needed to meet global regulatory requirements.

• Represent Regulatory CMC in project teams and provide strategic regulatory CMC input to ensure successful product development

• Work closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in the implementation of Regulatory Strategies to meet the Company Goals

• Plan and participate in the preparation of Health Authority meeting requests, briefing books and responses to Health Authority information requests

• Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies.

• Lead and participate in Regulatory interactions with Health Authorities (HA), as appropriate.

• Develop Regulatory CMC strategies and Risk assessments for assigned projects.

• Identify areas of continuous process improvement and engage RA teams and key stakeholders as necessary.

• Support in providing interpretation of global CMC regulations and guidelines, to the company personnel for assigned programs

• Provide support during Health Authority inspections as necessary.

• Escalate issues that affect regulatory compliance, promptly to CMC RA Management

• Maintain up to date knowledge of global regulations and guidances pertaining to CMC issues

Experience, Education and Specialized Knowledge and Skills

• Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science required. Master's Degree or other advanced degree preferred

• 10 or more years Regulatory CMC experience and/ or related Pharmaceutical industry experience required.

• Experience in biologics required

• Thorough and extensive knowledge of FDA, EU and global regulations required

• Significant experience in developing regulatory strategy for complex products and experience in the preparation of CMC sections for complex regulatory submissions Excellent understanding of IND, CTA, BLA and MAA processes.

• Experience in engaging with health authorities on regulatory CMC topics

• Proficiency in Mandarin Chinese (spoken and written) is highly desirable

• Proficient user of standard of Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

• Strong computer and database skills

• Attention to detail, accuracy and confidentiality.

• Clear and concise oral and written communication skills

• Excellent organizational skills

• Critical thinking, problem solving, ability to work independently.

• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.

• Communicate effectively and articulate complex ideas in an easily understandable way

• Prioritize conflicting demands.

• Work in a fast-paced, demanding and collaborative environment.

This is the pay for this position

Pay Transparency

$190,000 — $237,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

The company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the company’s Talent Acquisition team at  [link for members]  to obtain prior written authorization before referring any candidates to the company.

The company Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.