Head of Regulatory Affairs (Management Jobs), Romblon in Romblon, Mimaropa
JOB RESPONSIBILITIES
Identify regulatory opportunities and find innovative ways to address and mitigate regulatory risks.
Develop and maintain positive relationship with all stakeholders either internal or external including key opinion leaders and key influencers in regulatory bodies industry associations while building Abbott Nutrition s credibility and trust.
Provide input into developing Abbott Nutrition positions on emerging issues and implement plans to respond, influence or mitigate.
Collaborate with stakeholders to influence and shape related legislation impacting the business.
Mitigate potential losses, and identify opportunities in legislative/regulatory area.
Manage key relationships within trade associations, advocate for Abbott s position on key topics, and when necessary, take leadership role on key issues relevant to the business.
Support senior leadership on interactions with trade associations
Managing team to ensure timely submission and approval of quality best in class regulatory documentation (including product submissions/re-registrations, novel ingredient applications, additive petitions, claims petitions and deficiency responses); analyze and identify regulatory requirements against project needs.
Managing team to identify documents and provide guidance to ensure technical dossiers are effectively presented to the regulatory agencies for timely registration/approval.
Partnering with medical, marketing, sales manufacturing in advising on regulation and law concerning the nutrition industry in order to widen and increase the knowledge on regulatory environment
Provide timely up to date information on current and emerging rules, regulations laws to ensure all business partners are kept abreast and can act accordingly
Ensures compliance to SOPs relevant to market practices and required ethical standards.
Ensuring compliance with Abbott Nutrition guidelines, local regulations for the different territories and codes of practice
Maintain a high level of product knowledge through familiarity with scientific literature for all Abbott Nutrition products and the pipeline portfolio.
Develop maintain updated knowledge of applicable current global/regional nutritional regulations and guidelines (e.g. Codex).
Attendance of relevant external international and local regulatory conferences to maintain subject matter knowledge
Motivate, develop and reward team in high performance culture, aligned as per HR policies and practices; to ensure engagement and productivity
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Qualifications
Education: Bachelor s degree in food technology/nutrition/pharmacy/science related field. Preferred: Physician, Medical Degree, PHd, Master s degree or advanced education in food technology/nutrition/pharmacy/science.
Minimum of 10 years prior experience in Regulatory, R D, Medical, Quality or related area, preferably in nutrition.
Experience interfacing with government regulatory agencies and proven skill at developing and implementing successful regulatory strategies.
Strong communication skills to effectively present regulatory information in writing and verbally to management, KOLs and government agencies.
Strong problem solver and developed innovative solutions
Highly self-motivated, prioritization skills
High precision, high quality detail work
Scientific analytical
Factual and structured communication style
Effective team player
Adaptability, Initiative, Innovation, Integrity, Team-work.
Ability to Lead, Set vision strategy, Build our organization inspire our people, Know the business, Drive for results, Make difficult decision, Encourage open exchange of ideas knowledge., Managing Performance, Strategic Acumen, Judgment, Interpersonal Acumen,
Knowledge on regulatory process in Philippines including Intellectual Property Right, Halal Kosher certification, GMP, importation license
Company
Global Diversified Pharmaceutical and Medical Products Company
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