Haleon Life Sciences Job – Global Regulatory Affairs Role
Haleon Life Sciences Job – Global Regulatory Affairs Role. Haleon vacancy for Manager- Global Regulatory Affairs CMC for life science candidates. The details are attached for the Latest Lifescience job in RA below. Interested candidates can apply now.
Name of the Post: Manager- Global Regulatory Affairs CMC
Req. ID – 513662-gsknch
Location: Hyderabad, India
Type: full-time
Category: Regulatory
Job Description –
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
The purpose of this role is to be responsible for the regulatory CMC activities for new registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products within the category and in particular the regulatory CMC strategy of new
product developments and major CMC changesJob Responsibilities:
- Responsible for CMC regulatory matters relating to registrations and/or life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio. Preparation of CMC sections of new registration files, PIFs, MDTFs, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions.
- Interacts with colleagues in other global functions (e.g. Category, BU, Quality and Supply Chain) to deliver high quality CMC sections for dossiers, PIFS or MDTFs including documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance.
- Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
- Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records e.g. change controls.
- Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree/master’s degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) other related discipline.
- Experience with standard operating procedures, and legislative requirements
Regulatory document management experience, including experience with Documentum databases and MS team sites - 12+ years’ experience in regulatory operations (or similar) role
Hello friends, we are providing you with some of the interview questions and answers here that you can expect at the time of the interview for the Latest Lifescience job in RA. All the best for your interview!!!
Question: Can you describe your experience in handling regulatory CMC activities for new product registrations and life-cycle maintenance? Answer: Certainly. In my previous role, I was responsible for managing regulatory CMC activities for a defined portfolio of products. This involved preparing CMC sections for new registration files, PIFs, MDTFs, clinical trial applications/INDs, and responding to regulatory agency queries. I have successfully handled variations and renewals, ensuring regulatory compliance and technical congruency. Over my 12+ years of experience, I have developed a deep understanding of regulatory requirements and guidelines, enabling me to facilitate timely and complete submissions.
Question: How do you ensure effective collaboration with cross-functional teams like Category, BU, Quality, and Supply Chain to deliver high-quality CMC sections for regulatory dossiers? Answer: Collaborating with cross-functional teams is crucial for delivering high-quality CMC sections. I believe in establishing clear communication channels, holding regular meetings to align priorities, and sharing updates on regulatory requirements and guidelines. By building strong partnerships with authors and subject matter experts, I ensure technical congruency and regulatory compliance in the CMC sections. This approach facilitates a seamless flow of information and enhances the efficiency of the regulatory affairs process.
Question: How do you stay up-to-date with technical guidelines and regulatory requirements relevant to your field? Answer: Staying up-to-date with technical guidelines and regulatory requirements is essential in this role. I have a proactive approach to continuous learning and keep myself informed through various channels. These include attending regulatory seminars and workshops, subscribing to industry newsletters, and actively participating in regulatory forums. Additionally, I maintain close connections with regulatory agencies and industry peers to gather insights into the latest trends and updates in the regulatory landscape.
Question: Can you share an example of a challenging CMC change you encountered and how you ensured regulatory compliance during the process?
Answer: Certainly. In one instance, we had to implement a major CMC change for a critical product in our portfolio. The change involved altering the manufacturing process to improve efficiency while maintaining product quality. To ensure regulatory compliance, I initiated a thorough CMC evaluation and engaged with relevant stakeholders to assess the impact of the change on product specifications, stability, and safety. I prepared a comprehensive regulatory submission and diligently followed up with the internal compliance records, including change controls. By proactively addressing potential regulatory concerns, we successfully executed the CMC change while meeting all regulatory requirements.
Question: How do you manage regulatory document management, and what experience do you have with Documentum databases and MS team sites?
Answer: Regulatory document management is a crucial aspect of my previous roles. I have experience working with Documentum databases and MS team sites to maintain up-to-date technical product records and support document control processes. I ensure that all regulatory documents are organized, version-controlled, and easily accessible to the relevant team members. My familiarity with these tools enables efficient collaboration and helps me track document approvals and changes. Additionally, I ensure that all documents comply with standard operating procedures and legislative requirements, guaranteeing the integrity and accuracy of the regulatory documentation.
Editor’s Note: Haleon Life Sciences Job – Global Regulatory Affairs Role. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
