Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)
For our client, we are seeking a Director, Drug & Device Combo (autoinjector/inhalation) Reg.-cmc (remote) to join the team of a leader in the Pharmaceuticals & Biotech space. This role will drive meaningful impact across key initiatives and partner cross-functionally to deliver measurable outcomes. You will work closely with stakeholders to execute against strategic priorities and scale performance. The position offers the opportunity to influence both strategy and execution in a high-growth environment. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $190,800 – $300,300 annually
Responsibilities
- Lead Device Regulatory Affairs strategies for various delivery system programs
- Support the drug-led CMC Product Team in regulatory activities delivery
- Write and review technical content for regulatory documentation such as IND/CTA and NDA/MAA submissions
- Identify and escalate potential regulatory issues to leadership
- Ensure compliance with regulatory requirements and maintain market supply
- Conduct activities with efficiency, accuracy, and safety standards
Qualifications
- 10+ years of relevant experience in biological/pharmaceutical research or regulatory CMC processes
- Experience with drug product life cycle phases, from development to marketed status
- Strong background in scientific content review and regulatory documentation preparation
- Proven ability to assess technical arguments critically and support data-driven conclusions
- Bachelor’s degree in biological science, engineering, or related field; advanced degree preferred
Benefits
- Comprehensive healthcare coverage including medical, dental, and vision insurance for employees and families
- Retirement benefits with 401(k) plan options
- Paid holidays and vacation days
- Compassionate leave and sick days available
Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs. Apply tot his job Apply To this Job