The Senior Director for Scientific Affairs, working with members of the Sciences and Regulatory Advisory Board (SRAB), other Scientific Affairs personnel from Member companies, and the GPhA Team, assists in the development of GPhA’s Scientific Affairs initiatives as well as Member communications and training opportunities for these initiatives.
Essential Duties and Responsibilities:
Serve as primary point-of-contact for FDA – is the “line of communication” between GPhA and key FDA offices (OGD, OPS/OPQ, CDER, DTP, OC, OAR, etc.)
Serve as primary point-of-contact for USP – is the “line of communication” between GPhA and USP
Member Sciences and Regulatory Initiatives
Facilitate discussions and actions, coordinate requests/recommendations from members for relevant projects/issues/etc., and facilitate discussions and actions between members and the FDA. Examples include but not limited to:
- Bioequivalence Initiatives
- Serve as FDA-Industry liaison on all bioequivalence initiatives
- Drug Substance
- Serve as FDA-Industry liaison on all drug substance initiatives
- Quality by Design Initiatives
- Serve as FDA-Industry liaison on all QbD initiatives
- Quality Metrics Initiatives
- Serve as FDA-Industry liaison on all QM initiatives
- Stability Initiatives
- Serve as FDA-Industry liaison on all stability initiatives
- ICH Initiatives
- Serve as FDA-Industry liaison on all ICH initiatives
- FDA Guidances/Rules
- Serve as FDA-Industry liaison on all Guidance/Rule initiatives
Member Communications/Training Opportunities
Assist in the develop of and delivery of timely and relevant communication and educational opportunities to members on relevant Scientific Affairs issues
Conference and Workshops (Responsible for substance and subject matters)
- Fall Technical Conference
- CMC Workshop
- ANDA Basics Workshop
- Labeling Workshop
- Develop other training/education workshops and conferences as appropriate
Other duties as assigned per priority adjustments (Per 2013/2014 GPhA Strategic Plan)
Duties to also include:
- Overseeing and coordinating scientific, regulatory, technical and quality initiatives with all related federal and state agencies.
- Leading the initiatives related to global regulatory review and approval processes, including evaluating and coordinating global regulatory strategies for all ongoing programs. Also, formulate and effectively communicate, at all levels, the overall regulatory strategy.
- Establishing a positive and collaborative rapport with relevant US and international regulatory agencies.
- Assuring the quality of documents that are assembled to support all relevant GPhA science and regulatory activities.
- Will take a proactive role in developing long standing relationships with preferred GPhA stakeholders and coalition members.
- Manage meetings/expectations with Regulatory Agencies and/or other groups, as needed.
- Will represent GPhA whenever leading a cross-industry workgroup in an area of expertise.
- Ability to make difficult judgment calls within sphere of responsibility. Demonstrate advanced negotiating, influencing and motivating skills, with the ability to identify and resolve issues at a senior level within GPhA and Member organizations.
- Ability to communicate effectively at all levels across the GPhA Member organizations, consistently demonstrating confidence and authority.
- Author/co-author timely articles on the changing global regulatory landscape. This may include development of whitepapers, position paper, etc. to highlight GPhA’s end to end capabilities in this arena.
- Ability to monitor evolving regulations regarding generic product development in regions/countries of interest to GPhA. Conduct internal gap analysis for all technical skills and capabilities that are needed to support generic product development.
- Serve as the Regulatory Subject Matter Expert (SME) for GPhA. Able to build out knowledge and capabilities within GPhA to include thorough understanding of generic product development and approval requirements.
- Enhance GPhA’s regulatory communication strategy. Coordinate communication with other SMEs for product development and approval strategy.
- Relevant regulatory experience in developing strategy for generic product development and approval.
- Serve as the liaison for communication and collaboration with regulatory experts from around the globe (EU, Asia, Latin America, Africa, IGPA etc.).
Education, Skills and Experience Requirements
- Master’s Degree in Chemistry, or a science related field required; Doctorate preferred
- Experiences of at least ten years in the generic pharmaceutical and/or with the FDA, specifically the OGD (both experiences preferred)
- Ability to work effectively in a small company environment
- Regulatory strategic experience from generic product development through product approval and post-approval product monitoring systems - direct ANDA filing experience for small molecules a must
- Management experience overseeing regulatory staff
- This individual should have hands-on problem solving skills including full failure analysis and preventive measurement processes
- Communication and interpersonal skills that can influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
- Strong software and computer skills, including MS Office applications
- Excellent oral and written communication, time management, and team-oriented leadership skills are essential
- Acts as a role model for professionalism and a respected ambassador for GPhA, remaining effective in difficult, stressful and/or highly sensitive situations
- Other experiences and attributes:
- Training and education commensurate with position
- Careful planning to achieve accurate and timely results
- Work precisely according to procedures, rules and regulations
- Collaborate with outside organizations to promote GPhA goals
- Work in a collaborative manner with Members and other partners
- Work in a collaborative manner with US and International government agencies
This position is based in Washington D.C.
The Association provides competitive compensation and a comprehensive benefit program. GPhA is an Equal Opportunity Employer.
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