Director Regulatory Affairs & Compliance

Biocodex is a French family-owned pharmaceutical company headquartered in Gentilly, near Paris, France. The company was founded in 1953 to develop and market the world’s first probiotic yeast strain, Saccharomyces boulardii CNCM I-745®, discovered in 1923.

Building on relationships established for nearly 70 years with healthcare professionals, the Biocodex teams work daily for the health of all and focus their activities around three main areas:
• Microbiota to educate the general public and healthcare professionals on the growing importance of microbiota, advance scientific breakthroughs in microbiota by funding academic research, provide solutions for preserving microbiota health with its unique probiotic drug Saccharomyces boulardii CNCM I-745®, innovate with its
Symbiosys® range and make early-stage investments in start-up companies
• Orphan diseases for patients with severe orphan pathologies around the world, such as DIACOMIT®, which is indicated for the treatment of Dravet syndrome, a rare and very severe form of epilepsy in children
• Women’s health with the Saforelle® brand for women of all ages.

With more than 1,600 employees, Biocodex generated net revenues of above €500 million in 2022, including 42% in France and 58% internationally. The group is present in 115 countries through wholly owned subsidiaries in 16 countries and a network of distributors worldwide.

POSITION SUMMARY

The Director of Pharmaceutical Affairs & Compliance (DPA) is responsible for leading the Biocodex dietary supplements subsidiaries regulatory strategy and ensuring compliance with all relevant laws and regulations. This role will oversee the review of promotional materials/messaging, labeling, and packaging, provide leadership in the strategic guidance and execution of regulatory concepts within cross - functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. This position also oversees the development, implementation, and maintenance of the subsidiaries compliance program and reports to the Head of Pharmaceutical Affairs, North America.

YOUR RESPONSIBILITIES

Regulatory Compliance

• Collaborating with the Head of Pharmaceutical Affairs to establish and implement the Biocodex Regulatory Compliance goals and short and long-term strategic objectives. The DPA will create functional strategies and specific objectives to support Biocodex’s future growth and operational effectiveness.
• Collaborate cross functionally with new product concepts, claims, and formulations to create a competitive advantage for Biocodex. Align with internal key stakeholders and with the company’s business goals and objectives, while ensuring regulatory compliance in product formulation, labeling, and advertising.
• Championing a Culture of Regulatory Compliance throughout the organization and leading continuous improvement efforts.
• Monitor regulatory developments and advise the company on potential impacts and necessary actions.
• Manage interactions with regulatory authorities, including the FDA and state agencies.
• Oversee the maintenance of regulatory documentation and records.
• Provide training and guidance to the team on regulatory compliance issues.
• Develop and implementing robust regulatory and compliance policies and procedures in alignment with Regulatory and Corporate Compliance requirements.
• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by FDA and FTC, and by attendance at major industry/FDA meetings (when appropriate).
• Collaborate with Global Regulatory Affairs to support the U.S. Commercial strategy and strategic imperatives.

Corporate Compliance

• Collaborating with the Chief Compliance Officer, develop the subsidiaries healthcare compliance program in accordance with the laws applicable to our industry, the “Program Guidance for Pharmaceutical Manufacturers” published by the Office of the Inspector General- Health and Human Services, the Federal Trade Commission (FTC), National Institutes of Health (NIH), Office of Dietary Supplements (ODS), and the Federal Sentencing Guidelines.
• Develop appropriate policies and procedures to support compliant business interactions are achieved, and related subsidiary guidance is created, adopted, published, and communicated to all employees.
• Develops, coordinates, and administers effective compliance training programs for all appropriate employees and management on pertinent laws, regulations, policies, and procedures, including in-depth training of key functions and field personnel. Maintains accurate and updated training records.
• Develops and implements auditing, monitoring, and reporting programs.
• Establishes and implements periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk.
• Conducts semi-annual Compliance Committee meetings.

QUALIFICATIONS

• Minimum of 7 years of experience in regulatory affairs and compliance within the dietary supplements or consumer health.
• Experience in the category of dietary supplements, Probiotics, and Gut Health is a plus.
• In-depth knowledge of FDA regulations, DSHEA, GMP, and other relevant regulatory guidelines.
• Proven ability to develop and implement regulatory strategies and compliance programs.
• Strong leadership and management skills, with the ability to lead cross-functional teams.
• Excellent communication, negotiation, and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities.

REQUIREMENTS

SKILLS, ABILITIES, AND TRAVEL

• A reliable team-player with strong organizational, project management, detail oriented, and communication skills.
• Proactive work style.
• Ability to be resilient, flex, and adapt to internal and external change.
• Work collaboratively across the organizations.
• Autonomous and ability to work in fast-changing and multi-tasking environment.
• Ability to manage and communicate in a scientific and medical environment.
• Strong management and leadership capabilities
• Excellent writing skills.
• The US MSL position is associated with a minimum of 60% time in the field while- customer facing.

EDUCATION

Bachelor's degree in Chemistry, Biology, Engineering, or related field.

WHY BIOCODEX
Our four values are driving forces and bonds for all teams: we play collectively; we shape fair relations; we dare to innovate; we care for our ecosystem.

At Biocodex, we do not discriminate on the basis of gender, age, disability, nationality or sexual orientation. In fact, we welcome diversity, which we recognize as a source of strength for the company.

At Biocodex, our CSR approach is an holistic one to reconcile the « 4P’s »: « People, Planet, Profit and Purpose » and we also ensure that our employees are provided with necessary and relevant tools for both their personal and professional development, while offering them competitive advantages and services.

Join us!

Take up the challenge and send your application!