||Director of Regulatory Affairs
||Scientific and Regulatory Affairs
||Vice President, Scientific and Regulatory Affairs
||Exempt, Full Time
This is a non-supervisory role that directs and manages PDA volunteer-driven project activities. The primary focus is on project development, volunteer team management, and execution of quality regulatory and technical content. The incumbent facilitates the work of PDA Task Forces and other volunteer teams across their life cycle. The Director is also expected to provide input into the quality and regulatory business activities and strategy of PDA, including through the work of related PDA Advisory Boards. The role supports PDA program planning committees, the work of PDA Education and TRI, as well as other internal PDA departments as needed. The role also facilitates external interactions with regulatory and policy bodies relevant to PDA’s mission, both domestic and international. In this position, the Director may oversee several department and PDA processes.
Duties & Responsibilities
Technical and regulatory content development through volunteer management and facilitation:
- Manages the activities of PDA’s Regulatory and Quality Advisory Board (RAQAB), including PDA responses to global draft regulatory and policy documents.
- Provides input to technical reports and other written deliverables as part of publication process
- Manages, participates in, and may lead approved Task Forces and other writing teams or volunteer bodies through their entire life cycle to develop deliverables on time and within budget through:
- Effective meeting planning, preparation and management and preparation in consultation with team leads and co-chairs
- Removal of administrative road blocks, so teams can focus on content creation, may act as primary PDA point of contact for task force members
- Facilitation of team building and consensus among team members at meetings and staff members at PDA
Project and Portfolio management within SRA and PDA
- Encourages integration of SRA activities and deliverables with other departments within PDA as appropriate to the project
- May contribute to the activities of PDA Interest Groups, assist them in developing deliverables and facilitate communication with ABs
- Supports PDA meetings to focus on outcomes which drive efficiency and productivity
- Contributes to the development and publication of electronic surveys
- Participates in program planning committee activities, provides technical support and input to internal PDA departments as needed
- Participate in establishing and maintaining department standards and processes
- Performs all other duties as assigned
External communication with domestic and international regulatory and policy bodies
- Serves as PDA’s primary administrative focal point for regulatory correspondence
- Monitors, researches, and facilitates the development of PDA policy positions in a timely manner
- Assures timely submission and process adherence for formal communications with regulators and other agencies
- Bachelor’s Degree or higher in a related field and 15 years equivalent experience or equivalent combination of education and experience.
- Demonstrated professional excellence in field or fields relevant to the mission of PDA.
- Documented sustained level of professional achievement and contributions in a relevant field(s)
- History of public contributions to scientific, technical, and/or quality and regulatory affairs activities in the pharmaceutical and biopharmaceutical industries.
- Service and history of contributions to PDA-sponsored activities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Ability to take direction, and accomplish tasks efficiently, on time and accurately;
- Excellent organizational skills: Ability to prioritize work and to organize an office environment;
- Ability to work independently with minimal guidance as well as within a team;
- Ability to apply sound judgment and use discretion when dealing with sensitive information;
- Excellent interpersonal, analytical and communication (both written and oral) skills;
- Ability to work in a team-oriented environment; both internally and externally with volunteers, while respecting boundaries as appropriate
- Knowledge of Microsoft Word, Excel, PowerPoint, Outlook, Visio:
- Technical skills needed: background and experience in the development, manufacture, and regulation of pharmaceutical and biopharmaceutical products, particularly parenterals and injectables, current knowledge of domestic and international regulatory and compendial requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to independently ascend and descend stairs;
- Ability to independently reach, twist and bend;
- Ability to independently remain stationery for extended periods of time; and
- Ability to independently lift up to 30 pounds when required by work assignment.
How to Apply
Please send a cover letter and resume to [email protected].
PDA Offers An Impressive Benefits Package, Including
- Generous paid time off – 13 paid holidays, 12 sick days, 2 personal leave days, and 16 vacation days per year to start.
- An annual 401(k) retirement plan.
- A comprehensive individual and family healthcare plan (medical/dental/vision/prescription), PDA pays 100% of employee only coverage and 80% dependent coverage.
Employee Acknowledgement: I have read the above position description and I understand and agree with the terms and requirements for this position. I also understand and agree that such requirements may be amended and/or adjusted at anytime.
Persons with mental and physical disabilities as defined by the American’s With Disabilities Act are eligible for this position as long as they can perform the essential functions of the job after reasonable accommodations are made to their known limitations. If the accommodation cannot be made because it would cause the employer undue hardship, such persons may not be eligible for this position.