Job Title: Director Regulatory Affairs CMC

Job Description

In this role, you will provide CMC strategy input, authoring, and oversight of CMC-related regulatory items to ensure regulatory compliance of our products.

Responsibilities

• Collaborate with cross-functional teams and regulatory authorities to help drive CMC regulatory strategies, submissions, and approvals.
• Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans.
• Provide strategic guidance on CMC aspects of regulatory submissions including INDs, BLAs, and ex-US submissions.
• Author and review CMC-related regulatory documents for submissions, including Module 2.3, Module 3, IMPD, CMC-related briefing documents, and other CMC-associated documents.
• Provide oversight and coordination for the development of CMC portions of regulatory authority submissions.
• Collaborate with internal teams and external partners to ensure adherence to global regulatory guidelines and requirements.
• Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and Regulatory Affairs.
• Manage interactions with health authorities for CMC-related matters and prepare responses to inquiries.
• Proactively identify and mitigate potential CMC regulatory risks or roadblocks, developing contingency plans as needed.
• Participate in regulatory authority inspections and audits, as required.
• Review and approve CMC regulatory documentation, ensuring compliance with regulatory requirements.
• Provide CMC regulatory support for post-approval CMC-associated commitments as well as post-marketing CMC activities.
• Drive continuous improvement initiatives related to regulatory processes, standards, and practices.

Essential Skills

• Bachelor’s degree, preferably in a scientific field.
• A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.
• Knowledge and experience with authoring and preparation of global regulatory submissions (IND, CTA, BLA, MAA), post-approval, and post-marketing regulatory CMC activities.
• Knowledge and experience with current Good Manufacturing Practices (cGMP), CMC regulations, and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
• Experience with CTD format and content.
• Ability to work independently and in a group setting and to interact effectively with different functional areas.
• Detail-oriented with a focus on quality and compliance.
• Strong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
• Strong demonstrated experience with Microsoft Word, Project, and authoring templates.

Work Environment

The position is onsite in Vacaville.

Pay and Benefits

The pay range for this position is $82.00 - $101.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Vacaville,CA.

Application Deadline

This position is anticipated to close on Mar 14, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $82 - $101