Director of Regulatory Affairs - Sanford Rose Associates - CWF

Position Description

Director, Regulatory Affairs

The Company

Our client is a global resource for pharmaceutical, biopharmaceutical, medical device, personal care and health care product companies addressing the needs of its global customer base in North and South America, Europe and Asia.


The Position

Based in a lovely country-like area outside of Philadelphia and reporting to the Vice President, Regulatory Affairs, the Director, Regulatory Affairs will provide leadership in establishing systems and guidance for the activities of the Regulatory Affairs organization that are in harmony with the company’s strategic initiative and the goals of the business. This person will also develop services and initiatives with internal and external customers that bring value to its customers, particularly with respect to the regulatory environment.

In addition, the Director, Regulatory Affairs will be responsible for the following:
· Assist with the development, implementation and coordination of regulatory strategy based on current regulations, industry best practices and the impact on products and processes.
· Have shared responsibility for the submission of all DMF, 510(K) submissions, and supplements as required.
· Formulate partnering initiatives with internal and external customers to develop, implement and expedite regulatory processes with global regulatory agencies.
· Support and develop the company’s “regulatory” positions on various strategic issues relating to product, product usage and services. Develop variations in concepts that can be discussed for strategic positioning.
· Represent the company at professional meetings and as a member of key committees in industry associations.
· Assist in training and developing other members of the regulatory team via formal training plans.
· Actively educate external customers on regulatory issues relating to the company’s products and services. This education should be positioned from a “value to customer” perspective.
· Assist the international sites on matters, as needed, (eg. NA submissions, etc).
· Provide continuous regulatory support and information during product development and production for products or services that are regulated by the FDA to assure regulatory and customer expectations are met.
· Actively educate other internal groups.
· Support other areas as requested.
· Perform other miscellaneous responsibilities as required.

Candidate Requirements

· BA/BS degree, preferably in the life sciences with the relevant business background. An advanced degree would be a plus.
· Must be a hands-on performer with a minimum of 10 years experience in regulatory affairs with several years leading, managing and mentoring other regulatory affairs professionals.
· Must have a minimum of five years in management with direct communication with the FDA.
· Practical experience in preparation, submission and maintenance of 510K’s. Experience with IND/NDA’S preferred. Experience with other regulatory applications as well as advanced knowledge of U.S. regulations, cGMPs and ISO.
· Regulatory experience with a large pharmaceutical or medical device company, or experience in a smaller company or in a division of a large company.
· Regulatory experience with a company that supports the medical device industry or pharmaceutical industry required, especially a company involved in API manufacturing, drug packaging or drug delivery systems.
· Experience pulling together the Drug Master File and keeping the DMF current.
· Must have a strong working knowledge of the FDA, prefer experience with CMC section.
· Must have strong organizational skills.
· Must have the ability to work well with people and have excellent written and oral communication skills.
· Ability to travel.


Compensation

Compensation will be competitive and commensurate with an individual’s background and qualifications and will include a base salary, an attractive incentive program and an excellent benefits package. Relocation assistance will be provided.

If you are interested in this opportunity contact Ann Harrison at Sanford Rose Associates – CWF at 1-800-850-9427 or annh@sanfordrose.com.

How to Apply

Application Instructions / Send a Resume