衡阳招聘

1. The preparation and execution of the international regulatory affairs departments intelligence strategy.

Led the implementation of regulatory intelligence ensuring strategy is aligned to the business needs;

2. Develop and implement systems for monitoring, analyzing and communicating international regulatory intelligence;

3. Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders;

4. Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information;

5. Synthesize information from global requirements database as well as interaction with local country experts as needed;

6. Experienced in understanding and interpreting regulatory guidelines and documents;

7. Independently prepare registration documents and develop registration plan for oversea markets;

8. Help ensure the quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations, and company standards;

9. Interface with international regulatory teams on regional regulatory strategy and implementation plans;

10. Develop and maintain knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs.

Requirements:

- BA/BS degree and 5+ years of experience in the pharmaceutical industry;

- 5 years in regulatory affairs; international division experience;

- Highly organized and able to work independently to meet deliverable on time and on target;

- Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all level;

- Attentive to details and focused on quality output;

- Regional regulatory experience required; global experience preferred;

- Business awareness and appreciation;

- Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously;

- Ability to communicate and interact effectively within department, and across departments.

    前沿生物药业（南京）股份有限公司成立于2013年，是一家立足中国、面向全球，具有国际竞争力的创新型生物医药企业，致力于研究、开发、生产及销售针对未满足重大临床需求的创新药。公司是中国艾滋病新药的领军企业、国家“十三五”新药创制科技重大专项“艾滋病药物专项”的牵头单位、南京市的“培育独角兽企业”。
    公司核心团队均具有丰富的国内外新药研发经验，公司现阶段专注于艾滋病抗病毒治疗及骨骼肌肉关节疼痛治疗领域新药的研发、生产及医学推广。未来，公司将持续加强创新药物的研发、生产及全球商业化能力，积极寻求与全球领先的科研机构合作，通过多途径来增强公司的产品线，为医生和患者提供更多元的治疗选择。
我们积极探索将创新的产品、完善的服务与卓越的全球商业化发展能力相结合，探索企业战略成功的路径。在推动业务成功的同时，以人为本、尊重和凝聚人才。始终坚持诚信与高道德标准，做负责任、创造高价值的优良企业，尽心竭力维护各方对我们的信任。
    前沿生物愿意付出长久、巨大的努力，志于提供创新药物和服务，为实现治疗重大疾病、改善健康水平、提高生活质量这一人类共同的社会发展目标做出积极贡献。

薪资福利待遇:
公司目前处于飞速发展时期，我们热诚欢迎各类有志之士和优秀人才的加盟。我们将为您提供良好的工作环境与氛围、具有竞争力的薪酬与福利待遇以及广阔的职业发展平台与培训机会。