Newly Created-Director of Regulatory Affairs (Pharma & Customs)

This position is for open for relocation.
Tyler Search Consultants is the leading Logistics and Supply Chain Management recruiting firm in the country.

*providing Nationwide exposure
*all levels - Executive, Management, Sales, Operations
*absolute confidentiality
*dedicated to the Logistics/Supply Chain Management Community - our specialty niche

**Please submit your resume as a Word document
attachment to bstevens@tylersearch.com

 ** Do not apply through this site**

 Director of Regulatory Affairs (Pharma & Customs)

 

Location: Philadelphia, PA

 

About Company: Leader in the global industry with worldwide sales.

 

Job Summary:

Comprehensive management for Regulatory Affairs in North America including management of Import and Export compliance of products and services to and from North America. Heads efforts to comply with all sets of laws governing the purchase, storage, sale and transportation of extensive product lines sold by the company and its subsidiaries. 

 

Duties/Responsibilities:

- Management of direct reports to include the setting of realistic goals, monitoring progress and validation of their proposed path forward to resolve problems and creating modification to priorities in a very dynamic environment.

- Interact with other departments to advise them of the regulatory requirements associated with each department and the changes and/or addition of business they propose to undertake. Evaluate the impact of these changes on the company including regulatory compliance, customer satisfaction and company profitability to the extent these parameters are tied to full regulatory compliance.

- Scrutinize total workload, complexity of changes required and budget to make the best possible use of available resources including existing staff, temporary help, consultants and outside lawyers.

- Individually monitor regulatory change and increase understanding of existing regulations for the diverse products that the company sells.

- Expand/revise Corporate Standards to ensure regulatory compliance. Make certain that all are updated as needed, and provide guidance on development of business/field SOP’s.

 

Skills/Qualifications:

- BS degree in pharmacology, chemistry, biochemistry, microbiology or related fields. Advanced degree in same areas is preferred. 

- 6  plus years experience in regulatory field and experience working with regulatory agencies. 5 years supervisory experience.

- Knowledge of the following regulatory areas highly desirable: Transportation of hazardous materials such as DOT, IATA and/or TDG.  Environmental compliance, such as, EPA hazardous waste disposal or RMP.  Security Regulations, such as, CFATS. OSHA Employee Right-To-Know, chemical labeling and MSDS requirements. FDA compliance for medical devices and drugs.

- Unusually excellent interpersonal skills with the ability to connect  with others and achieve their buy-in on compliance issues in situation where there is no direct line of authority.- Proven people management skills and ability to assess talent and performance in employees.- Strong background in coaching, mentoring and developing others.

**Please submit your resume as a Word document
attachment to bstevens@tylersearch.com

 ** Do not apply through this site**