Head of Regulatory Affairs

NinnionAustin, TX, United States23 days ago

About Ninnion Therapeutics:

As the world moves towards the first clinical approvals of Psilocybin, MDMA, and Ketamine, Ninnion is focused on creating a pipeline of next-generation psychedelic drugs and treatment protocols which combine psychedelics with traditional therapy as well as software-based intervention and support with unique, patentable patient interventions with regulatory exclusivity. Our development efforts focus on solutions which benefit all stakeholders by empowering patients, enabling providers, and reducing costs to payers. The company’s executive team and scientific advisory board of both industry and academic thought leaders, together with deep alliances and partnerships, bring unparalleled knowledge and experience to ensure success with a unique approach to developing better psychedelic medicines. Founded in October 2020, Ninnion is headquartered in Austin, TX. The company has an aggressive timeline to be in the clinic with its first pipeline candidate by the end of 2021 in an orphan pain indication. For more details, visit www.Ninnion.com.

Role overview:

Develops and implements the overall Regulatory Affairs vision, strategic direction and achievement of business goals for Ninnion’s portfolio, which would include early and late stage candidates in pain and mental health indications. The hired candidate will build, lead and direct a high performing team to ensure achievement of Ninnion goals.

The Head of Regulatory Affairs ensures compliance with industry best practices with all relevant government and company regulations. Responsibilities include assessing compliance with industry regulations, both external and internal, developing new policies, and training employees. As a startup, we are looking for leaders who are ‘hands-on’ and ready to roll up their sleeves.

The role reports to the CEO of the business and will primarily work from home, except for key meetings where in-person attendance is needed.

Key Responsibilities:

• Provide leadership and oversight for the Regulatory Affairs organization. Set strategies and priorities in alignment with Ninnion and function/business-specific strategies.

• Develop regulatory strategies for Ninnion’s development programs in alignment with corporate objectives. 

• Executes the regulatory strategies in the overall product development plan in collaboration with senior leaders in other functional areas. 

• Oversee global pharmacovigilance reporting and clinical trial transparency activities. 

• Accountable for all Ninnion communications with the FDA and other national regulatory authorities.

• Create and maintains quality management systems within Ninnion. 

• Lead interactions with US and EU consultants on development program strategies & supervise external regulatory operations vendors and promote the professional development of junior Ninnion regulatory and quality staff.

• Develop and implemen departmental Standard Operating Procedures and Regulatory Plans

• Support investor and other partner meetings as needed

Key Performance Indicators:

• Timelines and quality of regulatory interactions and submissions 

• Creativity and innovation in regulatory strategy development in a novel environment 

• Ensure retention of top talent and robust performance management

Professional Experience / Qualifications:

• Bachelor’s degree required at a minimum. Masters (including an MBA) or PhD. preferred in relevant scientific field

• 10+ years of regulatory experience in pharma / CRO industry

• Leadership experience within a matrix organization and across geographies and cultures.

• Specific experience with successful regulatory agency interactions for abridged and orphan indication strategies

• Excellent communication and interpersonal skills

• Understanding of biopharmaceutical field, technologies, players, market characteristics

Travel requirements:

Home based, with the exception of infrequent specific in-person meetings 

Behavioral skills:

• Self-motivated and proactive

• Highly entrepreneurial

• Being persistent and creative in solving customer problems

• Strong team player

• Strong interpersonal skills

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