Manager, Regulatory Affairs
Company: Hikma Pharmaceuticals
Location: Cherry Hill
Posted on: June 6, 2021
Responsible for defining detailed regulatory strategies and
submissions in support of existing marketing authorizations for
products at multiple manufacturing facilities. This position
ensures timely review of documents, managing submission timelines,
and FDA follow up as needed. Additionally, this position will be
responsible for supporting labeling activities for marketed
- Develop, communicate and execute regulatory strategies for
complex projects including maintenance of licenses/authorizations
for existing marketing authorizations. Review and approval of
changes controls and documents (batch records, specifications,
analytical methods, development reports, protocols, etc.) for
regulatory submission and compliance to FDA submission
- Active role in the generation and intradepartmental review of
new submissions, supplements, amendments and annual reports.
Support resolution of deficiency comments (CRLs and IRs) from the
- Represent or lead the RA function on assigned cross-functional
project teams. Ensure project teams, business objectives and
deliverables are aligned with regulatory strategy.
- Monitor applicable regulatory requirements; assure compliance
with company and external standards. Provide timely interpretations
of applicable Agency guidance documents and support rollout across
- Establish appropriate communication with the Agency, and relay
concise information within RA and other functions, primarily at
- Ensure that labeling is compliant with regulations, and in
agreement with Reference Listed Drugs. Will prepare and submit
labeling as necessary.
- Develop and document sound regulatory decisions and
BA/BS degree in related scientific discipline with a minimum of
6 years' experience in RA. Injectable dosage form and drug labeling
experience is prefered and knowledge of device CFR 820 regulations
is a plus.Sound understanding of U.S. Drug Regulations.
- Strong knowledge of both pre and post approval regulatory
- Understanding of the labeling regulations, including SPL, drug
listing, and facility registration requirements.
- Scientific knowledge of the pharmaceutical development and
- Ability to manage complex projects and timelines in a matrix
- Strong oral and written communication and presentation
- Demonstrated interpersonal skills including strong negotiation
and collaborative skills.
- Ability to independently identify compliance risks and escalate
- Ability to lead and coach others. Will be responsible to mentor
and assist in the development of RA staff.
Notification to Agencies
Please note that Hikma does not accept unsolicited resumes or
calls from third-party recruiters or employment agencies. In the
absence of a signed Master Service Agreement and approval from HR
to submit resumes for a specific requisition, Hikma will not
consider or approve payment to any third-parties for hires
Keywords: Hikma Pharmaceuticals, Cherry Hill , Manager, Regulatory Affairs, Other , Cherry Hill, New Jersey
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