||Vice President, Scientific and Regulatory Affairs
||Scientific and Regulatory Affairs
||President and CEO
||Exempt, Full Time
Provide high level scientific, regulatory affairs and quality systems support to the PDA membership. The position requires an advanced degree or equivalent experience, demonstrated management and organizational skills and the ability to anticipate association needs and fulfill them without being supervised. Substantial member, regulatory and industry contact is expected during normal duties, including frequent interactions with PDA Advisory Boards and Interest Groups, Industry Associations, and Standard Setting Organizations, as well as global regulatory agencies. Demonstrated ability to successfully communicate in multiple formats with the internal and external PDA Community is expected. Successful interpersonal skill set and experience managing and working in companies and committees/teams to meet goals. Successful in achieving consensus opinions. This position reports to the PDA President and CEO.
Duties & Responsibilities
- Create and execute PDA tactical plans, based on the Strategic Plan, to expand participation by members, to include new science, technology, regulatory and quality opportunities and initiatives, to provide a consistent and strong Pharma/Biopharmaceutical agenda.
- Support relevant PDA Advisory Boards, e.g., Bio Advisory Board (BIOAB), Scientific Advisory Board (SAB) and the Regulatory Affairs and Quality Advisory Board(RAQAB) and all its task forces, and PDA Interest Groups, assuring PDA science documents are completed, published and cited authoritatively on a timely basis.
- Interact effectively with other PDA departments to provide input on science and technology topics, content and speaker identification.
- Direct research projects involving internal and external resources.
- Serve as liaison with other outside organizations regarding Scientific, Regulatory and Quality projects of mutual interest. May assume global leadership of organization’s involvement with selected future Scientific, Regulatory and Quality projects or similar projects.
- Direct the activities of the department, and effectively manage staff and budget to accomplish these responsibilities to:
- Ensure Technical Reports, Standards, and other technical publications are generated and published.
- Analyze emerging scientific and technical needs of the membership, and work with the ABs and their task forces, other organizational planning committees and other volunteer leaders to recommend and implement strategies
- Develop training aids and other technical visual materials with volunteer committee input.
- Monitoring of regulatory initiatives and responses where appropriate.
- Day to day staff management, support and development
- BS/BA degree in appropriate science, quality or regulatory major from an accredited university
- PhD degree in appropriate science, quality or regulatory degree preferred
- Successful in consistently achieving the timely publication of scientific and regulatory documents, deliverables and publications
- Successful experience within pharmaceutical or biopharmaceutical manufacturing, quality and or regulatory affairs departments with working experience in global manufacturing, quality and regulatory systems
- FDA, EMA, ICH, PIC/S and/or other worldwide regulatory experience and relationships/contacts
- Successful public speaking
- Successful staff management experience
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents; ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community; ability to write speeches and articles for publication that conform to prescribed style and format; ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry; ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Must be able to deal with ambiguity and analyze and determine appropriate courses of actions. Ability to analyze detailed technical documents, as well as more general surveys and questionnaires.
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 abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to organize, prioritize and handle multiple, time-sensitive tasks; strong oral and written communication and interpersonal skills; must be team oriented and willing to assist others with critical deadlines as needed.
Direct the activities of the department to accomplish the goals of the group. Manage the budget to assure on/below spending while accomplishing goals.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Typical office environment.
- Occasional domestic and international travel is required.
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 travel worldwide;
- Ability to independently reach, twist and bend;
- Ability to independently remain stationary for extended periods of time; and
- Ability to independently lift up to 30 pounds when required by work assignment.
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.