Director of Regulatory Affairs

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Our client is an innovative, international leader in the biotech industry. They are manufacturing medications and medical processes that will revolutionize the healthcare industry as a whole and change the way we treat illness. They are hiring a Director of Regulatory Affairs to lead the overall planning, oversight, and execution of CMC regulations strategy.

The Director of Regulatory Affairs is responsible for the strategic planning and ensuring of regulatory affairs compliance and safety measures. This person will play a large role in the success of this organization in their beginning growth stage, while shaping manufacturing processes and programs as they see fit.

This Role Offers:

• Competitive base salary and comprehensive benefits plan, including medical/dental/vision, 401K match, generous vacation time, and more.
• Opportunity to develop niche skills in the highly competitive, newly developed, and technologically advanced biotechnology space.
• Company at the beginning stages of an incredible growth phase offering extensive career advancement paths.
• Highly experienced leadership with deep market expertise and product marketing experience.
• High degree of autonomy to bring fresh perspective to the business development team and restructure processes and relationships.
• Ability to help the company tap into a global marketplace and be a part of the key support system that leads to the next big breakthrough in biomed.

Focus:

• Develop and implement a CMC strategy for optimizing and controlling quality and minimizing risks.
• Manage documentation generation and compliance while addressing regulations, policies, procedures, and more.
• Direct program improvements by reviewing development strategy, program timeline, program budget, resources, and overall risk.
• Ensure regulatory files and processes are up to date and submitted for internal audits and site inspections.
• As a leader, oversee the team in executing strategy and initiatives for growth and overall operational excellence.
• Support the development of product control strategy, including risk assessments, and process characterization strategies.
• Interact cross-functionally with internal teams to coordinate compliance documentation and find/address areas of inefficiency.
• Execute plans in accordance with cGMP, ICH, and FDA regulations.

Skills:

• Bachelor’s degree in a related field such as Science or Biology, required.
• 8+ years of experience in biotechnology and/or pharmaceutical manufacturing and operations.
• 6+ years of proven experience within CMC regulatory affairs.
• Thorough understanding of chemical products compliance monitoring, regulations, and standards.
• Proven success drafting and writing compliance/regulatory documents, including contracts.
• Highly skilled in managing operational efficiency, strategic planning, and identifying risks.
• Strong management skills with the ability to dive influence and carry out strategy.
• Expert-level ability in handling multiple priorities and projects at once while meeting deadlines.
• Excellent written and verbal communication; comfortable delivering presentations to C-level executives and high-profile stakeholders.