Regulatory Affairs Manager _ ABU

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The Regulatory Manager is primarily focused on Business unit program management. This position is responsible for managing regulatory strategy and practices, to support both premarket authorizations and post-approval activities as well as provide regulatory and strategic assessments to support assigned projects. This position also supports the launch of new products and maintains regulatory compliance throughout the company. Assignments may include international relationships with agents, partners and/or distributors. Additional responsibilities include: the preparation and management of regulatory submissions, and contribute as a liaison with internal staff, partners, and regulatory authorities to identify and manage initiatives to improve department capabilities.

1. Regulatory Submissions (CMC): Oversees the preparation and filing of global submissions to regulatory authorities (BLAs, A/NDAs, Supplements, Amendments, Annual Reports and DMF updates), as well as, for support of client applications.
   1. Provides strategic guidance on FDA and global CMC regulatory requirements
   2. Compiles, reviews and approves CMC modules to support regulatory filings
   3. Reviews and provides regulatory decision with regard to acceptability of submission documents
2. Project Support: Provides tactical and strategic regulatory input and guidance on cross-functional teams.
   1. Project team involvement is as support member or as project lead, as assigned
   2. Communicate regulatory policy to internal teams and provide clarity on regulatory expectations and timelines
   3. Interface with partner organizations, consultants, etc. to ensure regulatory issues are met while protecting proprietary information in relation to submission activities
3. Technical Guidance: Utilizes and shares expert knowledge to resolve complex issues; Trains and coaches others in regulatory requirements.
4. Compliance: Assess and communicate regulatory requirements, ensuring activities are in compliance with applicable regulations and guidelines.
   1. Manages the coordination and preparation of internal/external audits and compliance in accordance with regulatory standards, as assigned
   2. Reviewing controlled change request for accuracy and regulatory compliance
   3. Ensures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims
5. Strategy Development: Actively contributes to the development and implementation of regulatory strategy and timelines for assigned projects and programs.
6. Life Cycle Management: Develop and execute project plans for change control, complex projects, new registrations and maintenance of existing licenses world-wide.
7. Surveilance/Intelligence: Maintains an active engagement with emerging and current regulatory requirements in various jurisdictions.
8. Interfacing with Authorities: Communicates and interacts with regulatory authorities.
9. Operations/Systems: Oversee the electronic publication and/or filing processes for global regulatory submissions.
10. Financial Management: Administers budget reviews against plans.
11. Influence/Leadership: Manages and provides leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes. Mentor and coach junior RA staff and other team members.

Qualifications:

• Bachelors of Arts or Science required; Major(s): Scientific discipline or healthcare preferred.
• Minimum 5 years with a B.S. Degree
• Minimum 2 years lead/supervisory experience
• Minimum 5 years FDA regulated industry experience, i.e. a pharmaceutical, medical or healthcare industry
• Biologics or medical device experience preferred
• Laboratory experience desired
• ERP/MRP system (SAP preferred)
• Excellent verbal and written communication skills with strong personal and interpersonal skills, including the ability to relate to and negotiate with others to build trust.
• Microsoft suite
• Solid understanding and working knowledge of US and International Pharmaceutical and/or Medical Device laws, regulations, standards, policies and guidance documents
• Understanding of the product and processes and the associated qualification activities are essential in preparing CMC documentation that support both domestic and international applications.
• Experience in reviewing and/or authoring CMC sections related to Regulatory submissions.
• The regulatory affairs professional must stay current with the changing regulatory agency climate and laws, interpreting regulations and providing sound strategic advice is essential. 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 whole department.
• Practices are generally defined such that incumbent 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.

Shift: Weekdays

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: $87,500 - $152,500 annually depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.

Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you require assistance applying for a position, please contact our HR Department at:

Human.Resources@jubl.com