Senior Director, Regulatory 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 Senior Director, Regulatory Affairs, CMC, is responsible for developing Regulatory Strategies and Submissions for the company products globally. This role will provide regulatory strategy leadership, for development, commercialization and life cycle management of the company products.

The Senior Director will work in close collaboration with cross functional teams including Manufacturing, Analytical, Supply Chain and Quality to develop regulatory strategies aligned with company goals. The Senior Director will bring hands on experience leading regulatory CMC programs in biologics and demonstrated leadership skills. This role is both strategic and hands-on and will be responsible for all the regulatory CMC activities.

Role and Responsibilities

• Develop CMC regulatory strategies for biologics at all stages of development from early Phase through marketing applications and post-approval changes.

• Accountable for providing high level strategic and operational regulatory direction on regulatory CMC issues globally.

• Accountable for leadership in strategic regulatory development plans and risk assessments, critical issue management and advice on Health Authority interactions.

• Responsible for ensuring the appropriate execution of all regulatory CMC strategies.

• Lead CMC content authoring, review, and approval of regulatory submissions, including INDs, IMPDs, BLAs/MAAs, supplements, and responses to health authority questions

• Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness

• Serve as Senior CMC regulatory lead on interactions with health authorities including leading the planning and preparation for Meetings with Health Authorities

• Assess regulatory risk associated with CMC and manufacturing decisions, and advise senior leadership on mitigation strategies

• Provide regulatory oversight for post-approval CMC submissions, ensuring consistency with approved dossiers and global regulatory requirements

• Serve as the Regulatory CMC subject matter expert on cross-functional teams

• Manage regulatory CMC aspects of relationships with collaborators and external manufacturing partners

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

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

• Contribute to and help scale regulatory CMC processes, tools, and templates

• Ensure compliance of the company Programs with global CMC regulations and guidelines

• Maintain current knowledge of global CMC regulations and guidance

• Mentor and Develop CMC Regulatory Talent and help in building a high-functioning Reg CMC Team

• All other duties as assigned.

Experience, Education and Specialized Knowledge and Skills

• Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science required and Master's Degree or other advanced degree (Ph.D, PharmD) preferred

• 15 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 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

$220,000 — $275,000 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.