Regulatory Affairs Manager Worldwide Expansion

Regulatory Affairs Manager- Pharmaceuticals- Rapid Growth Domestic & Worldwide Expansion! Our client, a specialty pharmaceutical company is searching for an experienced candidate with first hand or relevant experience in the successful implementation of new product lines.  This senior manager will report directly to the President and, working with the senior management team, participate in the selection and prioritization of product candidates, the preparation and submission of regulatory documents, and primary responsibility for the selection and continuous oversight of contracted manufacturers.  Essential Duties & Responsibilities · Liaison with regulatory agencies having jurisdiction over the company’s products· Plan and supervise regulatory strategy for recommendation to senior management, company Board of Directors, and implement such direction once approved· Coordinate regulatory functions and filings as part of the product development teams and interact closely with manufacturing, clinical and other R&D functions· Serve as an internal resource and expert for the company in the area of regulatory policy and strategy· Manage relationships with regulatory consultants when utilized· Review and approve regulatory filings prior to submission, including utilization of the company’s electronic document management and filing systems· Establish and oversee the programs of post-approval pharmacovigilance as may be required by regulatory authorities and make regular reports thereon to the Board of DirectorsRequirements· Ph.D. or MD in disciplines such as Pharmaceutical Science, Chemistry, and Biology· Masters Degree in Regulatory Affairs is highly preferred· 10+ years relevant experience in pharmaceutical small molecule product development Senior-level management of an approved new drug from development stages to market launch· Strong practical and executable knowledge of 505(b)(2) and NCE regulatory affairs· Strong practical knowledge of CNS and the regulatory affairs issues is preferred· Strong working knowledge of regulatory procedures and proven success in leading the coordination and preparation of document packages for regulatory submissions from all disciplines within the Company· Extensive knowledge and background working with the FDA and other regulatory agencies· Effective communication skills in English language (writing, speaking, comprehending) Knowledge of Microsoft Office package including Word, Outlook, Excel, Project Commitment to the success of the business· Ability to work independently and as part of a team· Must be innovative, dynamic with ethical standards of integrity and quality, and caring attitude· Capable of performing other duties as assigned· Authorized to legally work in the United States without Visa sponsorshipIMPORTANT: Initially, you do not need to send me your resume, disclose your name or the company you work for. All you need to do is call me at 888.693.6887 ext. 221. I understand confidentiality is “critical” in relation to this opportunity as it’s more important for me to find the perfect match than to “initially” know your name. Communication in Confidence….888.693.6887 Ext. 221  Compensation: Compensation for this position ranges from $100k to $150K with bonuses ranging from 10-30% of base salary plus profit sharing and matching 401K. Benefits $100k-$150K base salary Generous vacation package and sick leave Production Bonus Very flexible and family friendly hours Generous Matching 401K plansAbout Us: MR of Sioux Falls, LLP is a full service staffing company that will assist you with both professional permanent placement as well as interim placement. Our 16+ years of service and reputation have allowed us to become recognized as a LEADER within the world’s largest network of executive search professionals, comprised of over 1,000 offices and 3,500 professional recruiters, by achieving the International #1 TEAM for last two consecutive years. We are looking for outstanding Healthcare professionals who pride themselves on their integrity, reputation and work history as “THE top performers” in their respected industries.  We work with these top caliber professionals to confidentially prospect and pursue their next outstanding opportunity in their career.For more information about our company please visit our website at www.agoodjob.com MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: US-SD-West/Rapid City JOB CATEGORY: Biotechnology and Pharmaceutical TYPE: Employee SALARY: 100,000.00 - 150,000.00 /year JOB REFCODE: AEC 0321-18 COMPANY: Management Recruiters of Sioux Falls CONTACT NAME: Andrew Cornett ADDRESS: 116 W 69th StreetSuite 200Sioux Falls,SD 57108 EMAIL: Apply by Email