Regulatory Affairs Senior Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

This role will provide accountability for the execution of operational tasks in the Regulatory practice area. This is a remote based role in the United States.

• Manages the preparation, assembly, publishing, and submitting of US and Canadian regulatory applications on behalf of PharmaLex clients.
• Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications.
• Drafts and manages regulatory submissions
• Drafts and manages drug listing submissions, establishment registration submissions and preparation of SPL files.
• Coordinates regulatory fee payments on behalf of client.
• Maintains knowledge of changing regulatory requirements and advises teams as appropriate (Regulatory Intelligence).
• Liaises with regulatory authorities on behalf of clients (e.g., US Agent).
• Builds, develops and maintains working relationships with clients.
• Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner.
• Performs basic document management tasks including file transfer, storage, tracking, and archival.
• Maintains familiarity with current global regulatory submission standards as well as departmental procedures.
• Other duties as assigned.

Education:

• Bachelor’s Degree and 3-5 years’ experience in Regulatory Affairs; or equivalent combination of education and experience.

Experience:

• Experience working in the pharmaceutical industry.
• Ability to prioritize and drive multiple projects.
• Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
• Understanding of FDA and Canadian Regulatory Affairs procedures, submission formats as well as industry standards and guidelines.
• Previous hands-on experience with managing and preparing original applications, amendments, supplements, annual reports, etc. for various application types including IND/CTA, ANDA/NDS/NDA/BLA.
• Ability to maintain confidentiality and responsive to client needs.
• Ability to adapt under regularly changing conditions.
• Outstanding organization, analytical, and problem-solving skills.
• Excellent written, verbal and presentation communication skills.

Skills:

• High attention to detail.
• Technical writing capabilities
• Experience in Microsoft Office as well as regulatory systems (e.g., document management systems, RIM systems etc.)

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What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: PharmaLex US Corporation