Job Description

The Regulatory Affairs Senior Manager holds accountability for ensuring full (end to end) regulatory compliance of defined projects, brands and/or portfolio including but not limited to new and existing products, packaging and communications. An established manager with a reputation for regulatory expertise and an increasing level of commercial acumen the individual actively navigates their internal and external network to influence outcomes and deliver with excellence.

Working independently with a high level of accountability:

Accountable for all aspects of in market regulatory compliance for defined projects, brands and/ or portfolio including, but not limited to, new and existing products, packaging and communicationsSupports  innovation/ new product development and renovation of existing products through, amongst others, review of product ideations; formula and raw material compliance review and assessment; development of new and review of existing claims: label development, review and approval; sales and marketing collateral including advertising, point of sale and web copy; registrations or licencing applications  Develop innovative regulatory strategies which enable a route to market for differentiated products and communications which are meaningful to consumers.Partners with regulatory and cross functional partners to co-develop effective and efficient policies, procedures and processesEnsures change controls are reviewed, approved and implemented within required timelines to maintain complianceDemonstrates expert understanding of all applicable Regulations, guidance and industry best practice and partners with internal stakeholders proactively to create and implement strategies to complyManages Regulatory Agency and submissions, as required e.g. FDA 30 Day Notification LettersHorizon scanning: Monitor the industry landscape with a particular focus on new regulations and relevant litigation ensuring early commercial awareness and impact analysisFollows Safety, Health, and Environmental policies and procedures.Provides leadership and training to direct reports and peers, as relevant and when required, and works to maximize their skills and potential.  Supports their career goalsOther projects and duties as required/assigned.

Qualifications

Experience & Education:

Functional experience: Extensive experience in a regulatory affairs role.Industry experience: Solid understanding of the consumer  healthcare/nutraceutical industry landscape and market trends.Leadership experience: Demonstrated leadership skills as part of a dynamic, high-performing team by setting and meeting goals and motivating cross-functional teams. Operational experience: Proven ability to build regulatory processes and systems. Quality experience/background is a plus.Technical expertise: Strong track record and technically savvy in the Regulatory Affairs function, able to provide expertise and guidance on product submissions with global health authorities.Stakeholder experience: Experience working with global, cross-functional teams desired.Education: Bachelor degree required; Advanced degree desirable.

Skills:

Shape strategy: Pro-active, creative, forward-thinker with the ability to think innovatively about integrated strategies for regulatory affairs while accurately anticipating future consequences and trends.Drive for results: In an environment where developing and introducing new products quickly and effectively is a key driver of competitive advantage.Lead innovation: Acts to surpass goals, seizing opportunities to push the envelope. Communicates direction or changes with clear rationale and appeal. Advocates for the new direction, and takes it onboard personally, even countering conventional practice.Disrupt & Challenge: Create Possibilities From New Thinking, Generate Disruptive Change, Lead Change.Collaboration/Trust: Exceptionally strong teamwork, collaboration, communication and leadership skills. Solid track record of building strong relationships across all levels of company.Positive Spirit/Vitality: Entrepreneurial spirit and enthusiasm to join a rapidly growing company. Executive presence, with ability to motivate team and influence effectively to the executive leadership level.Performance Orientation: Excellent business judgment and strategic thinking with strong problem-solving skills.Direction/Purpose: High level of integrity and trustworthiness. Commitment to excellence.