Associate Director, CMC Regulatory Affairs

Geron; California, Foster City (MO, CA); Remote; USD 170,000 - 185,000; Full time

Job summary

An innovative firm is seeking an Associate Director of CMC Regulatory Affairs to lead regulatory activities for its cutting-edge product candidates. This role involves ensuring compliance with regulatory guidelines, managing submissions, and collaborating with global teams to drive product development. Ideal candidates will have extensive experience in regulatory CMC, particularly in drug development, and a strong understanding of quality-related regulations. Join a dynamic team that values flexibility and offers a comprehensive benefits package, including generous time off and a robust retirement plan. This is an exciting opportunity to make a significant impact in the pharmaceutical industry.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Employee Stock Purchase Plan

Generous Time Off Program

Flexible Spending Accounts

Disability Insurance

Paid Leave for Life Events

Qualifications

• 7+ years of experience in regulatory CMC, preferably with oligonucleotide products.
• In-depth knowledge of regulatory systems and quality guidelines.

Responsibilities

• Act as the main point of contact for regulatory impact assessments.
• Support updates to IMPD/INDs for clinical trial applications.

Skills

Regulatory Affairs

CMC Knowledge

Project Management

Communication Skills

Technical Competence

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PhD, MD, PharmD)

Tools

Veeva RIM

Job description

Position Summary

The Associate Director of CMC Regulatory Affairs provides support for all CMC regulatory activities related to the ongoing development, registration, and life-cycle management of RYTELO (imetelstat) and other potential future development product candidates.

The position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Associate Director reports to the Senior Director, CMC Regulatory Affairs.

Primary Responsibilities

• Act as the main point of contact for completing regulatory impact assessments for all Company change controls for Quality-related changes using good understanding and working-knowledge of CMC post-approval guidelines and requirements for US (NDA) and EU (MAA)
• Provide CMC regulatory support and manage updates to IMPD/INDs to support all Company clinical trial applications
• Advise on implementation issues pertaining to CMC regulatory strategies for post-approval submissions (CBE-/PAS, Type IA/B-II variations, etc.) based on thorough understanding of regional (US and EU) regulatory requirements
• Support implementation of CMC regulatory strategies, including submission plans via eCTD, in line with the agreed business objectives
• Contribute to effective communications with the global CMC team on product development activities and post-approval issues
• Keep abreast of the changing CMC regulatory landscape to deliver knowledge management to the organization
• Support other CMC regulatory projects (e.g., conducting due diligence and supporting regulatory new initiatives) as needed
• Assist in the development of CMC regulatory standards, Company SOPs, and work instructions
• Participate in the preparation of meetings with regional regulatory agencies for CMC
• Support other US/EU/labeling and operations groups within global Regulatory Affairs on behalf of CMC regulatory as needed
• Provide review and input on updates to CMC regulatory documents (e.g., QOS/Module 3) for submission to regional regulatory agencies and contribute to preparation of registration dossiers (e.g., NDA and MAA)
• Work with project management teams as needed to develop regional marketing approval submission plans and timelines for CMC regulatory
• Support management of responses to any CMC questions from regional regulatory agencies in a timely manner and in line with the product strategy
• Contribute to management of other product lifecycle submissions for CMC as needed (e.g., DSURs)
• Work effectively with vendors and CMOs to successfully execute the above activities
• Ensure that appropriate, up-to-date records and health authority commitments are maintained for full compliance
• May have oversight of external regulatory contractors/consultants

Competencies

• In-depth knowledge and high level of technical competence of regulatory systems (e.g., Veeva RIM and Starting Point templates)
• Good working knowledge of the regulations and guidelines related to Quality
• Demonstrated ability to handle multiple projects
• Excellent English verbal and written communication skills
• Ability to work and thrive in a multi-cultural environment
• Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences within different time zones

Experience

• Bachelor's degree (or equivalent) in a scientific discipline is required; advanced degree (MS, PhD, MD, or PharmD) preferred
• At least 7 years of relevant regulatory CMC experience with a bachelor's degree
• Experience working on oligonucleotide products or peptides is an advantage but not essential
• Breadth of global CMC regulatory affairs experience in drug development and for commercialized products is required with a good all-round understanding of Module 3 content and requirements
• Experience in working with and leading project teams for CMC regulatory
• Demonstrated contributions to drug development and post-approval projects and implementation of CMC regulatory strategies is desirable

EEO Statement:

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company's comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron's intention to comply with all applicable federal, state, and local laws that apply to the Company's employees.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant's relevant skills, experience, and educational background. The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations.

General Salary Range: $170,000 to $185,000