新泽西招聘oncology RA manager or SM

Job Summary:

Manager or Sr Manager, Regulatory Affairs Strategy Oncology, is responsible for executing regulatory tactics  and strategies for all assigned products with the intention of achieving with the team successful registration and life-cycle management of unique and technologically complex products helping patients with cancer. This individual will, with a high sense of urgency, work together as a key team member with regulatory professionals to provide operational and strategic regulatory input to cross-functional teams responsible for development programs in USA and EU. The individual will also be responsible, together with other team members, for project management, communication and constructive working relationships with business partners and representatives of regulatory authorities.

Essential Job Functions:

Under the leadership of the Head of Regulatory Science, VP and the Senior/Executive Director, this Manager or Senior Manager is responsible for: 

· Leading regulatory IND/NDA submissions for assigned projects, including tactical and strategy support and executing tactics and strategy at the team level, for development of projects in oncology, aligned to overall R&D objectives from early development, through initial registration and as appropriate subsequent global expansion, and including implementation of new indications and formulations.

· Work together as a team member to collaborate with management and cross functional colleagues (including clinical development, drug safety, nonclinical and research and development, CMC, commercial medical affairs, business development) on regulatory submissions, regulatory insight for assigned projects, and advance drug development.

· Working together as a key team member, responsible for project leadership, coordinating resourcing and balancing project support across portfolio products developed for oncology indications. Provide submission planning support on project teams. There is opportunity for leadership and career development input.

· Assess and evaluate IND/BLA/NDA/CTA submissions, according to type of regulatory authority, and global region/country

· Represents the team and the company in contact/primary regulatory liaison with US FDA on assigned projects. As assigned, will lead or support the  delegation to regulatory meetings.

· Build positive relationships with FDA and other Regulatory authorities, in a spirit of working around the table, to ensure health and safety of patients.

· Monitor the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs. As assigned, will provide support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.

· With the team, will assess the impact of new regulations, guidances or enforcements and advise the broader Regulatory Group on requirements to maintain compliance with regulatory operations activities. 

· Will work together with the team to foster collaborative, efficient, and effective working relations with internal and external colleagues to further build the cordial working relationship between  and overall organization.

· Ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies.

· Other activities as required.

Job Requirements:

· Prior experience in the biotechnology and/or pharmaceutical industry in successful preparation and submission of IMPDs/INDs.

· Experience with Scientific Advice, MAAs/BLAs, post-approval life cycle management and supporting GMP inspections a plus

· Appropriate knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, EMA and FDA guidelines as appropriate for level

· Potential for development of leadership qualities including strategic thinking, innovation, people management, mentoring, scaling and collaboration

· Excellent regulatory operations skills, including planning and organizing

Experience / Education

 · Bachelor’s or Master’s degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields.

· 5+ years of relevant biopharmaceutical industry experience, with 3+ years experience in Strategy during new drug development with at least 2+ years of experience in Oncology.

· Practical Knowledge of US regulatory pathways i.e., 505b1, and PHS 351(a) required. Practical Knowledge of 505b2 and PHS 351(k) a plus. 

Knowledge / Skills / Abilities:

· Knowledge of drug development and regulatory policy; excellent scientific and business judgment.

· Ability to learn the process of providing strategic regulatory advice for the development of products through all stages of development including pre-approval and marketed compounds.

· Ability to develop the skills of managing complex issues and coordinate multiple projects simultaneously

· Work together in intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.

· Excellent interpersonal and written/verbal communication skills in English.

· Sensitivity for multicultural/multinational environment and understanding of the global pharmaceutical development process

· Ability to learn sound judgment as it relates to risk assessment

· Desire to learn new and emerging regulations and guidances, including understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information

· Willingness to assess the competitive landscape

· Self-organizing, self-directing, highly motivated with strong critical thinking and analytical skills.

· Working knowledge of global regulatory requirements and submission processes.

· Good interpersonal skills that involves working well in a team environment and the ability to lead and influence others.

· Collaborative and good organizational and planning skills; results driven.

· Effective analytical/problem solving skills.

· Ability to interpret global regulations, scientific and technical journals and legal documents.

· Ability to write procedures.

· Ability to effectively present information to internal and external partners.

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