(Senior) Manager - Regulatory Affairs ( Gene Therapy)
- Expired: over a month ago. Applications are no longer accepted.
Job Title: (Senior) Manager - Regulatory Affairs ( Gene Therapy)
Reports to (Title): Head of Regulatory Science
Location: Remote, US
Direct Reports : Yes
Department: Regulatory Science
EEO Job Category Professional
Manager or Sr Manager, Regulatory Affairs 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 to help patients with genetic diseases. This individual will, with a high sense of urgency, work together as a key team member with the R&D, clinical and CMC team to provide operational and strategic regulatory input to cross-functional teams responsible for development programs in US. 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:
- 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 of Exegenesis Bio, 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 Genetic diseases indications. Provide submission planning support on project teams.
- 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 Exegensis Bio US 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 within the overall organization.
- Ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies.
- Other activities as required.
- Prior experience in the biotechnology 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
- Bachelors or Masters degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields.
- 3+ years of relevant biopharmaceutical industry experience, with 2+ years experience in Strategy during new drug development with at least 1+ years of experience in Gene Therapy.
- Practical Knowledge of US regulatory pathways i.e., 505b1, and PHS 351(a) required.
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.
About Exegenesis Bio
Exegenesis Bio was established in July 2019 with focus on the development of gene therapy drugs. Its R&D pipeline covers CNS, Ophthalmology, Liver and other genetic diseases areas.
Exegenesis Bio is committed to developing in vivo and in vitro gene therapy drugs through viral vectors and non-viral platforms capabilities in front-end screening, optimization, production process, GMP production, and clinical trials.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
AddressSpring House, PA
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