Manager, Regulatory Affairs
LEO Pharma Inc. is a leading global pharmaceutical company specializing in dermatology and critical care. For 100+ years, our products have improved the quality of millions of people's lives around the world.
Headquartered in Denmark, we have employees in 50+ countries and our products are sold in more than 100 countries. To realize our vision of becoming the world's leading specialty pharmaceutical company within our focus areas, we are expanding into new regions and markets, reaching more patients and societies with competitive drugs and therapies that address unmet medical needs.
As LEO Pharma expands globally, we are searching for responsible, dedicated and creative people who are passionate about what they do, and who are determined to make a lasting difference to the field in which they operate.
Due to an expansion into the U.S. market, we are searching for a Manager, Regulatory Affairs who will partner with the senior management team and provide strategic regulatory support. Your goal will be to maintain positive relationships with customers and regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification and follow up of submissions under review.
Responsibilities:
· Provide input on promotional reviews, research protocols and reports · Evaluate and approve proposed changes to products and processes; develop, approve and implement U.S. regulatory plans based on these changes · Submit approved material with appropriate documentation to DDMAC in compliance with submission timelines · Plan and conduct internal audits, facilitate customer audits and audits by regulatory agencies · Make decisions on how data is presented to customers and agencies · Provide Regulatory Affairs training to cross functional groups · Assist with policy and procedure development & implementation in alignment with corporate headquarters policies. · Maintain responsibility for processing, investigating, final decision/disposition of investigation and response to customer complaints · Assist with agency audits by compiling and reviewing data that is to be presented to investigator · Maintain effectiveness of the quality system
Requirements:
· BA/BS degree in one of the life sciences; advanced degree preferred · 3+ years of direct regulatory affairs experience in the Pharmaceutical/Biotechnology industry · Experience developing and enhancing regulatory related SOPs · Excellent communication skills (verbal and written) · The ability and willingness to travel domestically and internationally as required
Would you like to be part of our success in the US? Please forward resume, cover letter & salary requirements to: Recruitment.US@leo-pharma.com (Att: RA-YG). An Equal Opportunity Employer MIS Ntwk Assoc Mtg Dates: Dec 28th No Mtg - Xmas Holidays Jan 4th Reg Mtg - 6 pm - Berman Larson Kane Offices, Paramus - DO NOT use GPS for directions - Bring 15 copies of your resume Feb 8th Combined Dinner Mtg - Assoc of Women in Computing - Totowa - Rod Colon - Networking: Do You Get It? |
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