Director, Regulatory Affairs

 

Due to the company’s expansive portfolio growth, the Evolved By Nature Regulatory and Clinical Affairs team is seeking a Director of Regulatory Affairs. This position will report directly into the Vice President of Regulatory Affairs and is responsible for supporting the Company’s business objectives within medical device, drug, and personal care programs by establishing and implementing regulatory strategy, managing submissions, and providing regulatory input within cross-functional teams.

 

Key Responsibilities: 

·      Responsible to drive strategy and preparation of product launches across business units (device, drug, and personal care). Represents department on cross-functional project teams. Independently develops regulatory strategic plan and provides guidance to project team.  Works with team to resolve complex project issues. Establishes product registration strategy and leads cross functional team in preparation of regulatory submissions. 

·      Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies, such as the FDA. Interact with key personnel in regulatory agencies to ensure timely resolution of issues during review of regulatory filings.

·      Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental registrations and approvals (e.g., IDE, IND, PMA, NDA, CE Mark, etc.) are obtained. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.

·      Able to negotiate with teams to ensure acceptance of regulatory strategy. Ensures compliance with project team timelines and company milestones.

·      Keep abreast of regulatory changes in all target markets globally across businesses. Provide interpretive analyses of regulation changes that affect Evolved By Nature’s products and operations. Advise personnel in other departments regarding their applicability and effect.

·      Develop and manage department procedures and systems to streamline regulatory operational activities.

·      Review and approve labeling and promotional materials for regulatory compliance.

·      Occasional domestic travel required

 

Qualifications: 

• B.S. in life sciences with 10+ years relevant experience
• M.S. or PhD in scientific discipline preferred; higher education may compensate for years of experience

 

Skills & Abilities:

·      Requires strong interpersonal skills, a flexible, collaborative, and team-oriented approach to problem-solving, and an ability to work in a fast-paced, rapidly changing environment.

·      Requires detail-oriented, self-motivated, organized, individual who is solution oriented

·      Requires excellent written and verbal communication

·      Reputation for integrity and ethical behavior

·      Strong analytical, problem-solving mindset

 

Other Requirements:

 

•  Able to obtain up to date Covid-19 vaccination status per the current CDC guidelines (full vaccination dose and booster) prior to employment start day.

 

 

Evolved By Nature is a new type of biotech company creating new molecules for a healthier future. With a belief that the next generation of products will advance the health of people and planet, we're using our sustainable molecule platform, Activated Silk™ technology, to create biomolecules, sustainable chemicals and natural ingredients that will increase the performance and decrease the environmental impact of everything from therapeutics to soap, to sneakers.