Job Description: This position brings strategic regulatory leadership to North America pipeline projects in the OTC drug, device, cosmetic, food or dietary supplement areas, with an emphasis on US OTC Monographs. Consumer focused, this position is expected to incorporate marketplace, technology and regulatory trends into well-crafted regulatory strategies. Builds strong relationships with all stakeholders, internal and external.
ROLE RESPONSIBILITIES • Strategy: o Provide regulatory leadership to NA cross functional project teams, pertaining to OTC Monograph Drug product development and launch, and business development opportunities. o Interacts and works collaboratively with multidisciplinary North American and global teams, ensuring regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success. o Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts within the region. o Uses internal and external networks to ensure regulatory strategies are robust and keep pace with dynamic regulatory environment • Execution: o Partner with project teams to ensure required regulatory contributions meet business needs and are provided to the project teams to agreed time and quality standards. o Ensures that an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the regional business are championed and communicated. o Regulatory review and approval of launch advertising and promotional copy. o Lead development of regulated labeling content for new products • External Engagement: Interpret and understand government regulations and industry code of conduct. Monitor, analyze and advise the business on existing and emerging regulatory trends and requirements. Engages in appropriate activities to influence the regulatory environment through other PFE colleagues, Agency contacts and/or Trade associations (as appropriate).
QUALIFICATIONS BASIC QUALIFICATIONS • Scientific bachelor or advanced degree required • Minimum of 3-5 years experience in Rx or OTC Regulatory Affairs, consumer products experience preferred
PREFERRED QUALIFICATIONS • Able to handle multiple projects and exercise good judgment in prioritizing tasks. • Demonstrate the ability to research and analyze information and develop regulatory strategies. • Demonstrate the ability to work independently and within a group setting, and to interact effectively with various functional groups. • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems. • Able to strategically influence and negotiate with internal and external customers • A high level of attention to detail.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process. G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.
Internal Number: 1000
About G&L Scientific Inc
G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Clinical Research and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of more than 2,500 global consultants, the key to G&L’s success is a straightforward, transparent approach; experience of unrivalled depth; and the recruitment and development of brilliant people. Indeed, the level of repeat business and ongoing long-term assignments is testament to the quality of service G&L provides.
Whether our client needs an individual RA professional or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings and flexibility in line with operational demands.
As well as excellence in our chosen fields, we are renowned for the quality of our people. Our real success lies in recruiting and developing brilliant consultants. We seek the right individuals to match our business needs, then build the environment that allows them to fulfill their potential. People join G&L Scientific for a variety of reasons. Some want to work with the very latest developments in Clinical Res...earch & Regulatory Affairs, others want the opportunity to make a real difference working in a dynamic and pioneering team. Ultimately, G&L people are free-thinking, proactive and creative individuals who are not afraid of change.
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