22 feb
Whatjobs
Estado de México
Oxford Global Resources is seeking a Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma company headquartered in Barcelona through our consulting services division.
Key Responsibilities: Oversee and manage the regulatory processes for international marketing authorizations (MAs) of pharmaceutical products, including those of the client and its subsidiaries.
This includes ensuring the maintenance of existing authorizations and obtaining new ones as needed.
Manage the lifecycle of pharmaceutical product MAs by preparing and organizing applications, dossiers for new authorizations, and submitting variations or extensions.
Provide guidance on regulatory strategies for new international registrations, certifications, and MAs.
Liaise with regulatory authorities, partners, and external service providers to ensure smooth approval processes.
Coordinate internal communication related to planned approval activities and post-approval processes, in line with applicable drug laws, EU regulations, and GMP guidelines.
Assist in evaluating external MA documents for in-licensing decisions through due diligence.
Serve as the primary point of contact for Health Authorities, stakeholders, and regulatory inquiries.
Prepare, review, and revise expert reports related to product approvals.
Draft, update, and adapt product information documents (e.g., patient instructions, professional information, packaging labels) for pharmaceutical products.
Utilize Data Management Systems (e.g., RIMS) for regulatory processes.
Requirements, Skills, and Qualifications: Bachelor's degree in Life Sciences or a related field.
Fluency in English for business communication.
Minimum of 5 years of experience in International Regulatory Affairs within the pharmaceutical industry, ideally at a global level.
In-depth knowledge of international registration processes and pharmaceutical legislation across key global markets.
Proven ability to collaborate effectively with partners and regulatory agencies, securing approvals and managing product lifecycle across various regions.
Knowledge or experience with Orphan drugs is a plus.
Familiarity with Data Management Systems (e.g., RIMS).
Strong attention to detail, with an ability to manage multiple priorities.
Excellent critical thinking, initiative, and interpersonal communication skills, with a proven ability to influence.
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