Global Head -RA
Apply NowCompany: Kashiv BioSciences LLC
Location: Koror, PW 96940
Description:
Job Type
Full-time
Description
Must apply / send resume directly to:
We are seeking a highly skilled and experienced individual to fill the role of Head of Regulatory Affairs and Compliance within our Biopharmaceutical company. The successful candidate will be responsible for the overall leadership and strategic direction of the regulatory affairs function within the company. This role involves ensuring the successful registration, approval, and post-marketing compliance of biosimilar products in global markets. The position will involve direct interaction with regulatory authorities, leadership of regulatory submissions, and collaboration with cross-functional teams to ensure the company's biosimilar products meet all necessary regulatory requirements.
Regulatory Strategy Development:
Develop and implement global regulatory strategies for biosimilar products to ensure timely approvals in target markets.
Oversee the planning and execution of regulatory submissions (INDs, BLAs, MAAs, etc.) and ensure alignment with business objectives.
Assess regulatory risks and provide strategic input to minimize obstacles to product approvals and lifecycle management.
Regulatory Submissions and Approvals:
Lead the preparation, review, and submission of regulatory documents, including clinical trial applications, marketing authorizations, and amendments.
Ensure the accuracy, quality, and compliance of all regulatory submissions.
Manage and coordinate responses to regulatory authorities' questions, ensuring timely and effective communication.
Regulatory Compliance and Intelligence:
Ensure all company activities comply with applicable regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
Monitor and interpret global regulatory trends, changes in regulations, and guidance documents relevant to biosimilars.
Advise internal teams on regulatory requirements, risks, and opportunities to ensure compliance throughout the product lifecycle.
Interaction with Regulatory Authorities and internal CFTs:
Serve as the primary contact with global regulatory agencies.
Lead and participate in meetings with regulatory authorities, including pre-submission meetings, scientific advice, and advisory committee meetings.
Negotiate and communicate effectively with regulatory agencies to achieve favourable outcomes.
Work closely with CFTs to ensure regulatory strategies are integrated into product development plans and ensure alignment with regulatory requirements and timelines.
Leadership and Team Management:
Build, lead, and mentor a high-performing global regulatory affairs team.
Ensure effective resource allocation, budgeting, and project management for regulatory activities.
Regulatory Labelling and Post-Marketing:
Oversee the development and approval of product labelling, including package inserts, patient information leaflets, and promotional materials.
Ensure post-marketing surveillance and reporting requirements are met, including safety updates and annual reports.
Manage post-approval changes, including variations, renewals, and line extensions, ensuring continued compliance.
Requirements
Qualification Required:
Masters in Pharma / Bio Pharma. (Regulatory Science, Pharmaceutical Science, Biotechnology etc.
Preferable experience in biosimilars and biologics products globally.
Experience and Skills Required
15+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role.
Extensive experience with regulatory submissions and approvals for biosimilars or biologics in global markets.
Proven track record of successful interactions with global regulatory agencies such as FDA, EMA, etc. and in-depth knowledge of Export and import regulations, including GCP, ICH guidelines, and local regulations
Full-time
Description
Must apply / send resume directly to:
We are seeking a highly skilled and experienced individual to fill the role of Head of Regulatory Affairs and Compliance within our Biopharmaceutical company. The successful candidate will be responsible for the overall leadership and strategic direction of the regulatory affairs function within the company. This role involves ensuring the successful registration, approval, and post-marketing compliance of biosimilar products in global markets. The position will involve direct interaction with regulatory authorities, leadership of regulatory submissions, and collaboration with cross-functional teams to ensure the company's biosimilar products meet all necessary regulatory requirements.
Regulatory Strategy Development:
Develop and implement global regulatory strategies for biosimilar products to ensure timely approvals in target markets.
Oversee the planning and execution of regulatory submissions (INDs, BLAs, MAAs, etc.) and ensure alignment with business objectives.
Assess regulatory risks and provide strategic input to minimize obstacles to product approvals and lifecycle management.
Regulatory Submissions and Approvals:
Lead the preparation, review, and submission of regulatory documents, including clinical trial applications, marketing authorizations, and amendments.
Ensure the accuracy, quality, and compliance of all regulatory submissions.
Manage and coordinate responses to regulatory authorities' questions, ensuring timely and effective communication.
Regulatory Compliance and Intelligence:
Ensure all company activities comply with applicable regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
Monitor and interpret global regulatory trends, changes in regulations, and guidance documents relevant to biosimilars.
Advise internal teams on regulatory requirements, risks, and opportunities to ensure compliance throughout the product lifecycle.
Interaction with Regulatory Authorities and internal CFTs:
Serve as the primary contact with global regulatory agencies.
Lead and participate in meetings with regulatory authorities, including pre-submission meetings, scientific advice, and advisory committee meetings.
Negotiate and communicate effectively with regulatory agencies to achieve favourable outcomes.
Work closely with CFTs to ensure regulatory strategies are integrated into product development plans and ensure alignment with regulatory requirements and timelines.
Leadership and Team Management:
Build, lead, and mentor a high-performing global regulatory affairs team.
Ensure effective resource allocation, budgeting, and project management for regulatory activities.
Regulatory Labelling and Post-Marketing:
Oversee the development and approval of product labelling, including package inserts, patient information leaflets, and promotional materials.
Ensure post-marketing surveillance and reporting requirements are met, including safety updates and annual reports.
Manage post-approval changes, including variations, renewals, and line extensions, ensuring continued compliance.
Requirements
Qualification Required:
Masters in Pharma / Bio Pharma. (Regulatory Science, Pharmaceutical Science, Biotechnology etc.
Preferable experience in biosimilars and biologics products globally.
Experience and Skills Required
15+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role.
Extensive experience with regulatory submissions and approvals for biosimilars or biologics in global markets.
Proven track record of successful interactions with global regulatory agencies such as FDA, EMA, etc. and in-depth knowledge of Export and import regulations, including GCP, ICH guidelines, and local regulations