Sr Manager, Regulatory Affairs

The position is responsible for scientific regulatory assessment, regulatory project leadership, and execution of pre-project work in their specific domain. The Sr Manager, Regulatory Affairs will proactively search for solutions for technical challenges. They will act as a core team member in addition to providing mentoring to develop RA colleague expertise.

This position will stay up-to-date on new regulations to ensure license maintenance, compliance and product life cycle management guidelines are maintained. This position is responsible for monitoring changes to regulations to determine the impact to potential new licenses.

Support to Project Development & Innovation: Partner with R&D and Innovation to define Regulatory requirements. Provide regulatory insights and expertise to ensure efficiency and compliance.

Project Management: Lead regulatory projects. Act as a project team member, bringing expertise and support for the success of the projects. Make recommendations in the pre-project phases. Propose innovative approaches and new scenarios to an existing or new development & registration. Guide project teams to build and develop regulatory strategy for pre- and post-approval to meet regulatory standards in a timely and cost-efficient manner.

Take End-to-End Regulatory sponsorship for development of Regulatory Strategy from Innovation through LCM phases, for continuous management of the necessary Regulatory Affairs activities. Prepare risk assessments and evaluations for complex matters related to manufacturing & clinical areas.

Interaction with authorities and consultancies: Prepare or supervise the preparation of technical meetings and teleconferences with local and global authority officials. Drive discussions with local and global authority officials, acting as an expert. Facilitate agency contacts by proposing and executing pre-submission meetings or scientific advice procedures.

Supervise or perform the planning of development and dossier preparation, including responses to authorities' questions to meet desired content (TPP and dossier specifics) and time to market. Handle on own or coordinate compilation and publishing activities of Regulatory Dossiers for the selected programs/projects.

Build and maintain relationships with regulatory agencies. Build advocacy strategy to onboard relevant regulatory agencies early on as part of programs and projects and advise on execution of it. Be involved in trade association activities and represent best interests of the company. Proactively identify, develop, and execute initiatives, programs, partnerships, coalitions and stakeholder networks, with the objective of minimizing regulatory and scientific barriers and/or leverage regulatory and scientific opportunities to support our growth strategy.

Review advertising, promotional and other related materials for assigned products to ensure compliance with applicable regulations, and guidance

Evaluate capabilities of external Regulatory Affairs consultancies, obtain new consultancy services opportunities, and evaluate the assigned work of consultancies selected for the assigned programs or projects.

Mentoring: Act as the internal point of reference for the area of expertise, supporting RA colleagues by providing solutions and mentorship. Mentor experts and specialists for technical skills as relevant with the necessary soft skills with support of HR. Provide regulatory intelligence, including interpretations of applicable or newly issued scientific and procedural regulations and guidelines. Support the development of the expertise of RA colleagues and contribute to the training program.

Due Diligence: Conduct regulatory due diligence on assigned potential in-Licensing opportunities. Build Regulatory license in programs for selected DD assignments after acquisitions.

• Shape solutions out of complexity - Is open and curious of other perspectives

• Client focus - Has in mind client's satisfaction

• Collaborate with empathy - Has a positive attitude towards collaboration

• Engage and develop - Clarifies short-term directions

* Drive ambition and accountability - Proactively manages own and others work

* Influence others - Communicates transparently

* Regulatory Affairs and Scientific Knowledge (expert)

* Defense Strategy & Defense expert report writing/ Scientific writing (expert)

* Mentoring (expert)

* Communication & Presentation skills (expert)

* Networking - Influencing and negotiating (expert)

* Project Management (advanced)

Bachelor's degree in Veterinary, Biology, Microbiology or other science related field plus relevant work experience in the production of pharmaceutical or biologic products. Master's degree in Veterinary, Biology, Microbiology or other science related field preferred.

Work Experience - 15 years of experience in development, production or testing of veterinary biologics, including experience using or preparing regulatory documentation supporting veterinary biologics marketing authorizations.

Expert working knowledge of USDA regulations for veterinary biological products and knowledge of biotechnology production.

• Must be able to read, write legibly and communicate in English

• Tasks frequently require prolonged, mental and visual concentration

N/A

Up to 5% of time for business travel, including local, regional and international

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal Contractor

**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

669B

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