Regulatory Affairs and Safety Associate
Reckitt
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- Regulatory Affairs and Safety Associate
- City: Islamabad
- We are Reckitt
- Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
- Research & Development
- In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
- The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
- About the role
The position reports to Regulatory & Medical Affairs Manager;
- Responsible for all Regulatory and Government Affairs functions internally including, submissions and acknowledgement of NDA, Variations, Renewals, Regulatory Intelligence and CARA etc.
- Support to Regulatory Affairs Manager in providing strategic & innovative solutions in regulatory affairs for business expansion along with regulatory compliance. Responsible for any other task (s) assigned by Regulatory Affairs Manager.
- To ensure the registration, renewals, and legal compliance of company’s products.
- Advise on and coordinate the approval of other changes related to company’s products/manufacturing site.
- Your responsibilities
- Accountable and Responsible for the implementation, maintenance, improvement, administration and updating of RB Pakistan in accordance with local Regulatory Affairs Legislation, Rules & Regulations.
- Collecting and collating a wide range of information and provide strategic inputs to management enabling them to take timely decisions for regulatory compliance.
- Keeping up to date with company's product range.
- Understanding and evaluating complex information.
- Advising company on regulatory requirements.
- Give on spot strategic input on regulatory rules and decision effecting local business after alignment with Regulatory Affair Manager.
- Resolving complex issues as they arise.
- Preparing and coordinating documentation.
- Reviewing company practices and providing advice on changes to systems.
- Liaising with, and making presentations to, regulatory authorities to solve all on going issues.
- Submitting license and clinical trials applications to authorities to get approvals as per timelines
- Submission of pharmacovigilance report to the authorities, as per their timelines
- Manage and facilitate all registration related activities and negotiate with regulatory authorities for Registration of company’s products
- Negotiating with regulatory authorities for price fixations and reviews.
- Maintain contact with regulatory authorities and company headquarters on regular bases
- Provide the company management with regulatory input to obtain timely regulatory approvals for the products as part of the product development Planning
- Quarterly Visit to PSQCA for submission of renewals and for any issues pending.
- Quarterly Visit to PFA for food product registration and for any issues pending.
- Upload all products both regulated and non-regulated on CARA
- Responsible for local Regulatory Intelligence Updates in RB system.
- Assist the RAM in all issues related to other Government Departments / Ministries / Division, whenever the need arises
- The experience we're looking for
- At least 3-4 years’ experience in the in the OTC / FMCG / pharmaceutical environment, with experience in regulatory and / or safety, sales / trade marketing / marketing roles.
- Must have approbation as bachelor’s degree in pharmacy, human sciences, chemistry, human biology or biochemistry, veterinary science / medicine
- Broad knowledge of Pakistan regulatory and healthcare systems
- The skills for success
- Commercial Awareness, Business Partnership, Collaboration, Partnership building, Regulatory, Dossier writing, Collaborator, Product Lifecycle Management, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Objective Setting, Business Strategy.
- What we offer
- With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
- Equality
- We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our co