Manager/Senior Manager Regulatory Affairs AND Quality Assurance - OTC/Consumer Healthcare Division:
My client, a small and rapidly growing, privately held specialty pharmaceutical company with both an RX Division as was as Consumer Healthcare Division, based in the Atlanta, GA suburbs, is focused on developing and marketing products of the highest quality. They plan to grow utilizing two approaches: developing and launching products, as well as in-licensing products and then developing and launching them.
The company has a robust pipeline, as well as a dedicated sales force to market their products. Their philosophy is to utilize a lean operating structure and partner with firms that have experience in manufacturing, formulation development and clinical trials.
Their goal is to earn and build trust, create a successful company and...eventually, change the world. In order to do this, they look for people with something to prove, results-oriented, the ability to act and do so quickly, and who like to have fun in a challenging and FUN work environment.
I am currently seeking a Manager or Senior Manager of Regulatory Affairs and Quality Assurance for the company's Consumer Healthcare Division. This is a new position as the company, and their needs, continue to grow.
TITLE: Manager/Senior Manager Regulatory Affairs & Quality Assurance -
OTC/Consumer Healthcare Division
REPORTS TO: Chief Medical Officer
SALARY RANGE: Up to $100,000 base for Manager level and to $115,000 base for Sr. Manager,
plus 20% target bonus, and stock options
RELO: Company strongly prefers local candidates. Relo assistance is minimal
(will reimburse up to $15,000 on relo, plus house-hunting
trip for family)
RESPONSIBILITIES:
The position is for Manager/Senior manager (depending on experience level) of Regulatory Affairs, including ad promo review and Quality Assurance. The individual will report directly to the Chief Medical Officer, who is part of the executive team.
The individual will be responsible for:
Assuring that company is compliant with all relevant FDA regulations and guidance pertinent to dietary supplements, medical foods and OTC medications
All manufacturing is outsourced, but the individual will be responsible for assuring quality of products, and compliance with appropriate regulations and guidelines by external service providers
There is currently one professional fulfilling this role in the company. Depending on the qualifications of the incoming individual the role could be supervisory in nature
Partner with the commercial group to develop win-win situations
REQUIREMENTS:
Bachelor's degree
5+ years experience of working in OTC/dietary supplements area, with hands-on experience of the dynamic regulatory environment including quality and manufacturing
Experience in both Regulatory Affairs AND Quality Assurance REQUIRED
Consumer Healthcare or OTC experience preferred, but will consider RX experience as well as long as have both REgulatory Affairs and Quality Assurance experience
Educational background in biological sciences or manufacturing, but hands on experience is more important than formal educational background
Demonstrated ability of a self-motivator and be able and willing to work in an entrepreneurial environment with a “can do” attitude
Must be roll up your sleeves type of person
Does this sound like the right opportunity for you? If so, AND you meet the minimum requirements stated, please forward your resume in WORD format to: sherri@parkwoodintl.com . Due to number of responses, only those candidates that most closely match my client's requirements will be contacted. NO PHONE CALLS PLEASE! I WORK BY APPT ONLY.
If this is close, but not an exact fit, I do specialize exclusively in pharmaceutical sales operations, sales training, marketing, business development, market research, etc. You can view my other openings via www.parkwoodintl.com, click on 'Opportunities', then click on 'Pharma/Biotech'. You may want to bookmark my site as I update it regularly. If interested in an opportunity, apply via my website or email your resume directly to: sherri@parkwoodintl.com . If there is a potential fit, I will contact you to discuss further.
