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MM15168 - ASSOCIATE DIRECTOR OF REGULATORY AFFAIRS
The Associate Director will have broad responsibilities for a variety of products, being developed for global markets. You will develop regulatory strategies, evaluate new product ideas, guide development projects, and support marketed products.

Responsibilities include:

Work on IND/NDA projects, Monograph products, and novel ideas that we transform into consumer products.

You will be the primary contact between the FDA and Wyeth for the products/projects that you manage.

You will have goals that will contribute to achieving our business objectives.

This position requires the combination of scientific and regulatory expertise, with OTC business acumen and professionalism to meet company objectives. You will assure timely and appropriate support for obtaining and maintaining product approvals, and extending product lines. FDA and FTC requirements must be met, and the incumbent will be proactive in providing creative solutions to the exciting challenges we face.

Additional responsibilities include:

Provide Regulatory guidance to the design of new product development programs.

Interact effectively at all levels of the organization, within Regulatory and across functions, as a persuasive advocate to achieve common goals.

Lead efforts to assemble and file INDs and NDAs, respond to FDA inquiries, and secure approvals.

Support the creation, review, approval and improvement of our labeling and advertising.

Keep current on OTC issues; review and assess FDA activities that affect our business.

Qualifications:
BS Degree; PhD preferred, JD welcomed. A minimum of 8 years of Regulatory Affairs experience, OTC experience preferred. Global experience is a plus. Strong analytical abilities coupled with creative problem solving skills. Excellent organizational and time management skills to simultaneously manage many projects. Solid collaborative, consultative and negotiating skills. Exposure to a broad R&D and/or regulatory experience; CMC, nonclinical, and clinical areas. Comfortable with minimal supervision while maintaining good communication. PC proficiency; e-NDA / CTD / e-CTD knowledge is a plus.

Submit Your Resume


	Home Who We Are For Clients For Candidates Job Postings Resources Contact Us	MM15168 - ASSOCIATE DIRECTOR OF REGULATORY AFFAIRS The Associate Director will have broad responsibilities for a variety of products, being developed for global markets. You will develop regulatory strategies, evaluate new product ideas, guide development projects, and support marketed products. Responsibilities include: Work on IND/NDA projects, Monograph products, and novel ideas that we transform into consumer products. You will be the primary contact between the FDA and Wyeth for the products/projects that you manage. You will have goals that will contribute to achieving our business objectives. This position requires the combination of scientific and regulatory expertise, with OTC business acumen and professionalism to meet company objectives. You will assure timely and appropriate support for obtaining and maintaining product approvals, and extending product lines. FDA and FTC requirements must be met, and the incumbent will be proactive in providing creative solutions to the exciting challenges we face. Additional responsibilities include: Provide Regulatory guidance to the design of new product development programs. Interact effectively at all levels of the organization, within Regulatory and across functions, as a persuasive advocate to achieve common goals. Lead efforts to assemble and file INDs and NDAs, respond to FDA inquiries, and secure approvals. Support the creation, review, approval and improvement of our labeling and advertising. Keep current on OTC issues; review and assess FDA activities that affect our business. Qualifications: BS Degree; PhD preferred, JD welcomed. A minimum of 8 years of Regulatory Affairs experience, OTC experience preferred. Global experience is a plus. Strong analytical abilities coupled with creative problem solving skills. Excellent organizational and time management skills to simultaneously manage many projects. Solid collaborative, consultative and negotiating skills. Exposure to a broad R&D and/or regulatory experience; CMC, nonclinical, and clinical areas. Comfortable with minimal supervision while maintaining good communication. PC proficiency; e-NDA / CTD / e-CTD knowledge is a plus. Submit Your Resume