Regulatory Affairs Manager (CH RA Lead)
Your Tasks and Responsibilities
- Contribute to business and regulatory objectives with APAC CH RA Head in implementing local regulatory strategic matters to fulfill the local business strategies in alignment with functional line manager. Ensures transparent, timely and efficient communication with business, supply chain and other local functions, regional/global Regulatory Affairs, providing regulatory expertise to achieve common decisions. Responsible for timely communication and alignment of regulatory timelines and strategies with local cross-functions in close cooperation with APAC CH RA Head and Global Regulatory Affairs.
- Ensures early identification of conflicts between projects and transparent and aligned prioritization where applicable:
a) Report the identified conflicts to APAC CH RA Head timely in order to meet country’s regulatory needs.
b) Ensures the preparation of the application files for products based on the documentation provided from global regulatory partners in accordance with local regulations, are of acceptable standard and quality to present them to the respective authorities. Liaise with Regional and Global Regulatory Affairs to obtain data required in support of registration applications to answer health authority queries.
- Able to manage assigned portfolio (e.g. preparation and submission of new applications, new indications, and post-approval variations) and follow through from submission to approval. Provide regulatory gap analysis, timely communicates to related functions & APAC CH RA Head.
- Where applicable, liaise with third parties/distributors/agents in relation to registration activities.
- Ensures regulatory compliance for a sustainable life-cycle management: Labelling and CMC changes are performed in accordance with local regulations and relevant Bayer SOPs.
- Ensures proper maintenance and update of product licenses in compliance with global standard and local regulations. Review packaging texts to ensure compliance with registration and legal requirements. Approve packaging artwork as necessary.
- Maintains global regulatory databases accordingly. Maintains product archiving of assigned portfolio in accordance to global/local SOP or OI: approvals documentation, correspondences filing and local dossier archive.
- Provides local RA intelligence: Identifies current and emerging national regulations which impact the drug development and / or marketing processes and ensures appropriate contribution and communication according to assigned responsibility.
- For assigned portfolio or projects, support LQR by providing regulatory expert input for LQR to manage product complaints, recall process, health authority interaction and communications including health authority inspections as locally relevant. Provide necessary functional input and documents to enable LQR to complete local compliance checks and develop local QSD process.
- Support and coach team members, conduct performance reviews, development dialogue etc. at required intervals.
Qualifications / Requirement
- Life Sciences based BS or MS with requisite experience and demonstrated track record. Preferably have experience in regulatory or drug/food supplement/cosmetics development experience in consumer health industry.
- Good in English and ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills. Convincing presentation skills are required. Able to demonstrate good cross-functional communication skills.
- Agility and readiness to learn and seek own solution. Analytical capability to evaluate complex situations and to proactively identify potential issues and future trends, translate and apply them to assigned portfolio. Ability to propose solutions while dealing with various environment aligned with APAC CH RA Head.
- Ability to focus on multiple issues at one time, ability to organize, prioritizes and direct diverse activities in changing environment often under time pressure.
- Ability to develop effective solutions to business problems, recognizing business needs, thinking strategically and develop risk mitigation strategies.
- Knowledge of local regulatory framework, compliance aspects related to regulatory affairs function and other relevant country requirements applicable to pharmaceuticals, food supplement and cosmetics is desired.
- A team player with ability to work in a team environment an possess strategic thinking and solution orient mindset.
- Pro-active approach with focus on adding value to the business.