Job summary
Job post source
This job is directly from Opella
Job overview
The Global Regulatory Lead at Opella drives regulatory strategy and execution to support Consumer Health business growth, focusing on Rx-to-OTC switch programs and regulatory submissions.
Responsibilities and impact
The role involves developing and implementing regulatory strategies, leading NDA submissions, preparing IND documents, engaging with regulatory agencies, reviewing labeling and advertising, researching FDA requirements, and supporting global regulatory initiatives.
Experience and skills
Requires a B.S. degree with 6-8 years of regulatory experience across NDA, Medical Device, and OTC classes; experience in Rx-to-OTC switches and software medical devices is preferred, along with strong communication skills.
Career development
Opella offers opportunities to grow new skills in a bold, collaborative, and inclusive culture that empowers employees to thrive and be at their best.
Work environment and culture
Opella promotes a challenger culture valuing honesty, courage, accountability, simplicity, and inclusivity, fostering a supportive and innovative work environment.
Company information
Opella is a global self-care company with a large portfolio in OTC and VMS markets, headquartered in France, with 11,000 employees, multiple manufacturing sites, and a commitment to health and sustainability.
Unique job features
The role uniquely focuses on Rx-to-OTC switch programs and involves cross-functional regulatory leadership in a global consumer health context.
Company overview
Opella is a UK-based manufacturer specializing in plumbing and sanitary products, particularly taps, valves, cistern fittings, and related components for both residential and commercial use. The company generates revenue by supplying its products to wholesalers, retailers, and original equipment manufacturers (OEMs) across the plumbing and construction industries. With a history dating back several decades, Opella has established a reputation for reliability and innovation, often focusing on water-saving technologies and compliance with industry standards. The company’s expertise in engineering and product development has positioned it as a trusted partner for major brands and distributors. Candidates should note Opella’s emphasis on quality, customer service, and its role in supporting sustainable water management solutions.
How to land this job
Tailor your resume to spotlight your regulatory expertise across NDA, medical devices, and OTC products, emphasizing experience with Rx-to-OTC switch programs and regulatory submissions.
Highlight your skills in preparing IND and NDA documents, managing regulatory agency interactions, and reviewing labeling and advertising to align with Opella's focus on compliance and innovation.
Apply through multiple platforms including Opella's corporate career site and LinkedIn to maximize your application visibility and reach.
Connect on LinkedIn with professionals in Opella's Regulatory Affairs or Consumer Health divisions; initiate conversations by referencing recent Opella product launches or expressing enthusiasm for their mission to simplify self-care globally.
Ensure your resume is ATS-friendly by incorporating keywords like 'regulatory strategy,' 'Rx-to-OTC switch,' 'IND submission,' 'NDA,' 'medical device regulations,' and 'labeling approval' to pass automated screenings effectively.
Leverage Jennie Johnson's Power Apply feature to automate tailored applications, identify the best job portals, and find relevant LinkedIn contacts, allowing you to focus on preparing for interviews and networking.
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