Director/Senior Director, Regulatory Affairs - Rockville, MD | Biospace
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Director/Senior Director, Regulatory Affairs

Sucampo Pharmaceuticals, Inc.

Rockville, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Areas of Expertise Desired:
Director, Regulatory Affairs,

Job Description

Sucampo Pharmaceuticals, Inc. (SPI) is currently searching for a Director/ Senior Director,  Regulatory Affairs for the US office located in Rockville, Maryland. SPI is a global biopharmaceutical company focused on innovative research and development of proprietary drugs to treat gastrointestinal, ophthalmic and oncology-based inflammatory disorders. Sucampo has a marketed product - AMITIZA® - and a pipeline including lifecycle management and clinical development programs. Sucampo is headquartered in Rockville, Maryland, and has operations in Japan, Switzerland and the United Kingdom.

Job Summary

The Director/Senior Director, Regulatory Affairs will assist with and/or manage regulatory strategy development, submissions development, SOPs development and compliance/ risk management programs. In addition, this position will assist with the execution of the U.S. and global regulatory strategy for Sucampo products, provide support to R&D and clinical project team(s), and have responsibility for review and approval of advertising and promotional materials, and product labeling.

Primary Responsibilities

•   Lead development of innovative regulatory strategy for all phases of drug development for assigned investigational drug products/programs.  
•   Serve as the regulatory interface for assigned product development teams, ensuring the business needs for the product(s) are met by anticipating, identifying, prioritizing, and mitigating regulatory risks while ensuring compliance with global regulatory requirements.
•   Work with cross-functional counterparts on the assigned product development team(s) and develop global regulatory strategy, contribute to early Target Product Profile generation, and messaging to be built into regulatory documentation, as well as the content of the product labeling.
•   Support the preparation of regulatory submissions in line with requirements and scientific and company policies and procedures.
•   Review global regulatory submissions to ensure they are complete, accurate and consistent with corporate objectives.
•   Accountable for development, submission and maintenance of DMEs, DMFs, NDAs, sNDAs, INDs, CTAs to the FDA and other global regulatory authorities.
•   Review and determine the applicability of supporting documentation for inclusion in regulatory submissions.
•   Provide operational guidance and review of advertising and promotional materials within the U.S. market across a number of therapeutic areas including, but not limited to, Gastrointestinal and Ophthalmology drug products.
•   Support administration and maintenance of the document repositories and document control areas for Regulatory Affairs (both paper and electronic).
•   Oversee in-house and external document publishing activities for paper and electronic submissions.
•   Support the labeling and/or change control processes to ensure timely and comprehensive review and approval of all packaging components (e.g., cartons, labels, Physicians Inserts, Patient Inserts, and Medical Guides).
•   Design, develop and enforce company compliance management programs to ensure adherence to all applicable federal, international and regulatory agency laws and regulations.
•   Develop, initiate, maintain and revise department practices, policies, and SOPs for all compliance and related activities. Support consistency and compliance to regulations and Regulatory SOPs across the organization.
•   Maintain up-to-date knowledge of regulatory requirements and communicate changes in regulatory information to project teams and senior management in a timely manner.
•   Work closely with senior management and key company employees as a resource on compliance strategy and risk management.


Job Requirements

1. PharmD or PhD in a scientific discipline preferred along with at least 8 years of experience in Regulatory Affairs
2. BS/MS requires 10 years relevant experience in Regulatory Affairs
3. A minimum of 5-7 years of Regulatory Affairs experience.
4. Must have in-depth knowledge of U.S. FDA regulations, guidance, and regulatory process pertaining to drug development, approval, and advertising/promotion, inclusive of CMC, clinical and non-clinical requirements for applicants.
5. Knowledge of international regulatory guidelines (e.g., ICH), GCP and GMP requirements is highly desirable.
6. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
7. Thorough understanding of electronic submissions for ICH/FDA compliance to electronic Common Technical Document (eCTD) standards is required.
8. Direct experience in the review of prescription drug advertising and promotion highly preferred, as well as prior interaction with OPDP.
9. Prior managerial experience, with direct supervision of senior level regulatory professionals, is highly desirable.
10. Excellent verbal and written communication, as well as interpersonal, skills are required.
11. Preferred candidates will have experience working in Regulatory Affairs across two or more geographic areas, and demonstrate proven skill at contributing to, developing, and/or implementing successful global regulatory strategies.
12. Strategic thinking, leadership skills, assertiveness, strong technical background, good business judgment, integrity, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
13. Must be goal and action-oriented, with excellent time management and organizational skills.
14. Detail-oriented, with high degree of accuracy and quality of deliverables.
15. high degree of initiative and the ability to work independently.
16. Sound knowledge in MS Office (Word, Excel, and PowerPoint), Adobe Acrobat and Microsoft SharePoint (preferred).

Sucampo Pharmaceuticals, Inc. offers a competitive salary and benefits package including 401(k) with a generous company match as well as company-paid parking or metro expenses. If this position meets your qualifications and interest, please submit your resume.

Sucampo Pharmaceuticals, Inc. is an Equal Opportunity Employer and is committed to embracing diverse backgrounds. Sucampo Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.

Sucampo participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United State.