Jubilant Pharma, LLC
Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a Manager, Regulatory Affairs to join our team!
What do we offer?
A culture that values growth and professional development opportunities, a highly competitive base salary, comprehensive medical, dental, and disability insurance programs, a group retirement plan, as well as health and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. As a fully integrated contract manufacturing organization, Jubilant HollisterStier has the capability to manufacture sterile injectable formulations, as well as solid and semi-solid dosage forms. Our four facilities in North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier proudly belongs to the Jubilant Pharma family. For more information, visit www.jublhs.com.
We will continue, with the greatest care for the environment and society, to create value for our customers and stakeholders by offering innovative products and cost-effective solutions through growth, profitability, and prudent resource investment. If you’re ready for a rewarding challenge, we invite you to take the first step and apply today!
Position Objective
The Regulatory Affairs Manager is primarily focused on Business unit program and regulatory management. This position is accountable and responsible for managing regulatory strategy and practices, to support both premarket authorizations and post-approval activities as well as provide regulatory guidance and strategic assessments to support assigned projects. Along with commercial, business development and management colleagues, supports the launch of new products and maintains robust regulatory compliance throughout the business unit. Assignment examples include : international relationships with clients, agents, partners and / or distributors; the preparation and management of regulatory submissions, and as primary or supportive liaison with internal staff, partners, and regulatory authorities to identify and manage initiatives to improve department capabilities.
Key Accountabilities
Responsibilities :
- Execute and manage technical and scientific regulatory activities.
- Completed work is reviewed from a relatively long term perspective for desired results. Individual is recognized as a discipline expert and resource in Regulatory Affairs.
- Practices are generally defined such that individual has the latitude to make daily, work routine decisions without prior discussion with management.
- External communication with government agencies and consultants where a fee for a service has been or is being developed, generally requires initial dialogue and strategy review with management.
- Provide regulatory decisions with regard to acceptability of submission documents.
- As an experienced participant in assigned product groups, person has influence on accomplishing compliance maintenance and supplement support.
- Person has impact on timelines for responding to operational needs.
- As a team member of projects, person is accountable to team in establishment of attainable timelines for his or her obligations and thus impacts the success of the project team. Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources and funds.
- Performs additional duties as assigned by Management.
Key Interfaces
External Interfaces
- Client Regulatory representative
Internal Interfaces
- Interactions with Quality assurance, Quality control, Engineering, Commercial, Validation and Product Development departments.
Education Qualification :
- Bachelor’s degree required (scientific discipline preferred); advanced degree
Desired Certification
- Regulatory Affairs Certification (RAC)
Experience Required :
- Minimum of 5 years of Regulatory Affairs experience in FDA regulated industry.
- Minimum of 2 years demonstrated leadership experience and the ability to work effectively in a multifunctional team environment.
Additional preferred experience :
- Experience interacting with the FDA and / or other health authorities.
- Experience in reviewing and / or authoring CMC sections related to Regulatory submissions.
Skills Required :
- Excellent verbal and written communication skills (in English) with strong personal and interpersonal skills, including the ability to relate to, and negotiate with, others to build trust; Command of written and spoken French a plus and desired.
- Computer literacy (Microsoft Office and SAP environment).
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- Ability to perform risk assessments or analysis.
- Individuals are expected to know how to research internal and external sources for solutions and propose guidance in the regulatory aspects of his or her product assignments. The person may be called upon by others in the Regulatory team to problem solve issues important to the entire department.
- Solid understanding and working knowledge of US and International Pharmaceutical and / or Medical Device laws, regulations, standards, policies and guidance documents.
- Position requires the understanding of the product and processes and the associated qualification activities are essential in preparing CMC documentation that support both domestic and international applications.
- Strong organizational, communication and project management skills.
- Expected to understand product / project issues, recognize external sources of guidance and regulations with the latitude to problem solve, negotiate, offer opinions, plans, and proposed actions to resolve issues.
- Must be able to negotiate resolution to challenges impacting Regulatory compliance and assist in creating reasoned and rationale strategies to guide the organization.
- Must demonstrate a collaborative work style, with a strong ability to build relationships, gain credibility and partner with internal customers and co-workers.
- Must stay current with the changing regulatory agency climate and laws, interpreting regulations and providing sound strategic advice is essential.
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