REPORTING TO APAC Director (expatriate)
On behalf of our client, a French pharmaceutical group and world leader in its therapeutic area, we are currently looking for a Regulatory Affairs Manager to join their regional office in HK. The Regional RA Manager will be responsible for driving implementation
of regulatory strategies for new product development and innovation and existing product registrations across APAC.
Provide regulatory expertise within the APAC organization, ensuing total compliance with the local requirements and regulatory norms of each country; provide validation support and technical advice to the medical, marketing and sales teams; anticipate problems
and actively seek alternatives and be proactive in proposing solutions. Track, review and circulate latest regulatory information.
Develop and facilitate relations with key regulatory authorities and decision-makers at a country level; discuss and challenge issues and negotiate solutions in the best interests of the company. As adequate actively participate to local pharmaceutical associations.
Proactively analyse and communicate any changes in the regulatory environment. Build the bridge between head quarter departments and distributors in order to find the best solutions in term of market access and accelerate the time to market.
Plan and control local Regulatory expenditure, ensuring cost-efficiency at all times and particular focus on controllable expenses. Manage and develop competencies of team’s members as well as be a role model and ensure teams follows the Compliance and HSE
- Provide overall local regulatory leadership, vision, strategy and expertise as regulatory project leader
- Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks and mitigation strategies.
- Attend international seminars and forums pertaining to product registration matters.
- Conduct regulatory planning strategy development and timely submissions & approvals of new pipeline products & new indications, and strong cross-functional partnership to ensure successful launches
- Monitor and communicate regulatory trends and policy to local & regional regulatory affairs management
- Prepare the local SOP to align with the company direction.
- Support new product development/modifications projects to establish and integrate regulatory submission strategies into project activities
- Provide the report of new regulations and the business impact .
- REGULATORY AFFAIRS OPERATIONS:
- Responsible for registration of products both under Cosmetics, Pharmaceutical product, Medical Devices or food supplement as appropriate.
- Maintain company’s licenses both import licenses and product licenses
- Ensure the company comply to related act e.g. pharmacovigilance, Safety Monitoring Program
- Ensure the company have all mandatory reports
- Ensure the various submission and approval for the business continuity.
- Communicate with Regional and Global Offices to get the right dossiers, prepare and submit registrations dossiers according to updated requirements e.g. ICH, ACTD and CSDT.
- Escalate and follow the updated procedures of Regional or Global Office to get the proper approval of new projects internally.
- Present registration dossiers to relevant government agency, discuss scientific issues and enhance/ expedite the progress of approval.
- Works with the Industry Association for the new regulations.
- Maintain and create good relationships with authorities.
- MARKETING and SALES
- Responsible for all labeling development, promotional material approval and other Regulatory Affairs including the post-marketing requirement.
- Provide the guidance to relevant associates for the promotional material approval.
- Provide regulatory support of marketed products.
- Work with cross functional associates e.g. Supply chain and Marketing to ensure the goods clearance at the port.
- Manage all systems for data base to maintain records of all registration activities, artworks labeling and promotional material approval.
- Bachelor degree or (preferably) higher in science, pharmacy, engineering, or a related technical field
- Minimum 8 years' experience in regulatory, R&D and quality (APAC or ASEAN regulatory experience preferred) in a MNC environment
- Strong knowledge of regulatory submissions, policy and procedures and analyse data using a logical and analytical approach
- Demonstrate advanced written communication skills in report writing and documentation; excellent project management skills
- Strong decision-making power, autonomous and multi-tasks oriented.
- Creative thinking
- Strong organizational, problem-solving skills
- Attention to detail.
- Ability to solve situations and close dossiers with rapidity
- Ability to priorize and to report the “to do list” in a proactive way.
- English, Mandarin required.