Manager, Global Regulatory Affairs - Pharma

Join our TRU Crew!

ChromaDex Corp. (NASDAQ:CDXC) is a global bioscience company dedicated to healthy aging. Our scientists’ partner with leading universities and research institutions worldwide to discover, develop, and create solutions to positively impact human health.  Our flagship ingredient, NIAGEN® nicotinamide riboside, is backed by clinical and scientific research.  Our consumer product is TRU NIAGEN® which safely and effectively increases NAD levels, a vital cellular resource, that supports healthy living and improving the way we age.

We need smart, collaborative people to help us build the next frontier bioscience company dedicated to enabling wellness and well-being for every demographic. Our culture encourages and supports continuous learning and improvement while helping individuals and teams achieve their full potential. We embrace diversity and inclusivity while promoting equality and fairness in the workplace. 

We are a flexible hybrid work environment with offices in Westwood CA, Tustin CA, and Longmont CO. We are dog friendly and people friendly, too!     

Who are you?

·  Whip smart - we’re looking for candidates with a keen intellect who quickly learn what they don’t know

·  Adaptable – Able to apply yourself on a wide variety of tasks on a daily basis

·  Analytical - Can assess and leverage systems and processes to figure out more effective ways to get things done

·  Hustle - Someone with a sense of urgency who does what it takes to get the best results

· Passionate – Yes!  About collaborating, about problem-solving, and about making a difference

·  You’re an ACE! – Great Attitude, Commitment to success, and Ethics in how you work and how you think

What’s the Role?

We are seeking a highly skilled and detail-oriented team member to join our team as a Regulatory Affairs Manager – Pharma. The successful candidate will oversee the regulatory activities related to Active Pharmaceutical Ingredients (APIs), ensure compliance with 503A and 503B compounding pharmacy regulations and lead the company’s IND and NDA efforts. This role requires a deep understanding of pharmaceutical science, regulatory requirements, international trade, and supply chain management.

Key Responsibilities:

API compliance:

Evaluate API compliance from current and prospective suppliers globally against stringent quality standards and regulatory requirements.

Collaborate with Supply Chain on negotiation of contracts and pricing with suppliers to ensure cost-effective procurement.

Coordinate with the Quality Assurance (QA) team to perform regular quality checks and audits of API suppliers.

Address any quality issues or non-compliance identified during inspections or audits.

503A and 503B Compliance:

Ensure all compounding activities comply with 503A and 503B regulations.

Develop and maintain Standard Operating Procedures (SOPs) for 503A and 503B compounding practices.

Conduct regular audits to ensure adherence to 503A and 503B standards and address any compliance issues.

Regulatory Compliance:

Stay updated on national and international regulatory requirements related to APIs, importation, and 503A/503B compounding.

Ensure all API-related activities comply with Good Manufacturing Practices (GMP) and other relevant regulations.

Prepare and maintain necessary documentation for regulatory submissions, inspections, and import activities.

Ensure compliance with API wholesale licensing regulations in all applicable jurisdictions.

Lead company pursuit of IND and NDA efforts for select API candidates.

Cross-Functional Collaboration:

Work closely with the Research and Development (R&D) and QA teams to understand API requirements for new product development.

Collaborate with the Production and QA teams to ensure seamless integration of APIs into manufacturing processes.

Provide technical support and expertise on API-related, import, IND/NDA and 503A/503B compliance matters to various departments within the organization.

What we need from you

§  Doctor of Pharmacy (Pharm.D.) or Bachelor’s degree in Pharmacy (B.Pharm) or related field.

§  Additional certification in pharmaceutical management or regulatory affairs is a plus.

§  Minimum of 3-5 years of experience in API management, quality control, or regulatory affairs within the pharmaceutical industry.

§  1 year of paid work experience in a pharmacy, wholesaler, or manufacturer within past 3 years or licensed pharmacist

§  Experience with GMP and regulatory inspections is highly desirable.

§  Ability to travel to supplier sites and manufacturing facilities as needed.

§  Strong attention to detail and organizational skills.

§  Commitment to continuous professional development and staying updated on industry trends.

Who we are:

We are an equal opportunity employer that operates with an emphasis that People Matter.  We respect and will consider every and all kinds of people regardless of race, color, religion, sex, sexual orientation, gender identity, age, natural origin, protected veteran status, disability, or any other factors prohibited by law or humanity.