Current Opportunities

Tracking # 54 Industry Pharmaceutical Jobs Job Title Sr Manager Regulatory Affairs (Early Stage Development) Location Richmond, VA Salary Open Job Description The regulatory manager/senior manager for early stage pharmaceutical development creates regulatory strategies, and liaises with global regulatory authorities, to negotiate efficient new product development plans that ultimately culminate with timely marketing approval. In this role, a regulatory manager/senior manager for early stage pharmaceutical products is a seasoned regulatory expert providing top level strategic regulatory expertise and regulatory development thought leadership for Company and the external community. Strong knowledge of US and Ex-US regulations and thorough familiarity with the drug development process, with focus in preclinical and clinical areas, are necessary to fulfill the position requirements. The regulatory manager is an intuitive team player who listens objectively, formulates opinions at meetings, exercises good judgment, asks incisive questions, and creates a constructive environment for all stakeholders in a development program. Qualifications The successful candidate should minimally possess: ·Bachelors Degree, Masters or PhD in a bio-medical science ·At least 10 years of relevant pharmaceutical experience, including 5 years of Regulatory Affairs in direct management experience. ·RAC certification preferred and Experience working US and international submission. ·Computer literate. Competencies ·Possesses good interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments. ·Skilled at research, logic, objectivity, good judgement, as necessary to formulate supportable opinions rapidly. ·Has strong technical writing, and documenation skills. ·Has strong reasoning ability to support and prioritize projects, adapt to shifting priorities, and resolve problems/conflicts. ·Has a strong knowledge and understanding of US and Ex-US regulations and thorough familiarity with the drug development process, (including both preclinical, and clinical development). Primary Responsibilities: ·Work with senior Management, Regulatory, Clinical, Scientific, Medical, Marketing and Finance colleagues to develop strategic plans for developmental efforts that will ensure the timely entry of new products to the market. ·Provide regulatory expertise to global product development and regulatory teams. ·Ensure that new products, new dosage forms and new indications are registered in a timely fashion. ·Provide planning and leadership to the Regulatory department by ensuring that appropriate structures, systems, competencies and values are developed, especially as they related to early stage drug product development. ·Draft, review and administer regulatory strategy and policy throughout the development processes. ·Actively liaise with regulatory authorities by leading meetings, managing correspondence, and providing follow-through. Negotiate with regulatory authorities for efficient and timely product review and approval. Lead internal colleagues in follow-through on regulatory commitments. ·Establish ongoing liaison with key opinion leaders and government officials, and ensure that significant developments in the field are identified and monitored. ·Ensure quality in the content of regulatory submissions, and assist the Regulatory Operations group in managing and submitting high quality INDs, CTAs, and other development applications around the world. ·Ensure that the interfaces between Regulatory and other departments are managed optimally. Provide effective team communication throughout the Regulatory department with suitable reporting systems, structures, and appropriate training. ·Provide coaching to other regulatory team members in various aspects of regulatory technical expertise and personnel management (HR issues, budgets, resource allocation). Relocation Package Yes Interview Expenses Yes Benefits Package Yes