Regulatory Affairs Manager- Oncology (International Markets)
We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Manager to join the Oncology team, which provides leadership and support for Gilead's Oncology product portfolio in the Intercontinental and Global Patient Solution regions (IC & GPS). The team works on a broad portfolio of products and can offer the opportunity to work on a diverse range of regulatory activities including strategic and technical advice from development through the product lifecycle.
This exciting opportunity for a regulatory affairs manager would allow you to strengthen your International experience in both a pre- and post-marketing setting. As part of the Oncology team you will be given opportunities to grow as a regulatory professional and quickly expand your knowledge and experience through the diverse range of regulatory activities you will be involved with. This role will be based in our Cambridge or Stockley Park office.
The International regulatory affairs team is responsible for supporting Gilead to make strategic decisions to enable access for patients to our molecules. IC & GPS team is responsible for territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East.
The regulatory department as a whole is built on a strong sense of team work. Core activities include planning, preparing and progressing new product registrations and subsequent post-approval safety and efficacy updates. The role involves cross-functional work with a diverse number of stakeholders both internally and externally to Gilead.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsible for leading regulatory strategies for designated products in the region. This ranges from new product licenses to lifecycle activities and have oversight of all regulatory aspects of the product.
Partner and collaborate with International Regulatory affairs, the Development, Commercial organizations and other cross functional stakeholders to ensure optimal execution of the agreed regulatory strategies.
Responsible for the preparation of regulatory submissions in the Oncology therapeutic area and execution of agreed strategies.
To establish strong relationships with Gilead affiliates and distributor partners and serve as the key contact person for their product.
The person in this role will have a deep understanding of the regulatory environment leveraging internal knowledge, experience and external regulatory intelligence
Responsible for the preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensures that any updates to the Product Company Core Data Sheet (CCDS) are submitted in a timely manner.
Liaises with regulatory, manufacturing and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling and agreed timelines.
Participates and contributes to regulatory team meetings and recognized as a knowledgeable resource for Regulatory Affairs for the wider organisation.
May participate and lead colloborative efforts across function in process improvements initiatives.
Will use Gilead systems for planning, preparing, tracking and storing submissions to regulatory agencies.
COMPANY CORE VALUES
Teamwork Excellence Accountability Integrity Inclusion
- Direct experience in regulatory affairs in pharmaceutical industry across International markets and in regulatory submissions.
- In depth knowledge of regulatory requirements, including ICH requirements and regional requirements. Has appreciation of current global and regional trends in Regulatory Affairs.
- Previous experience of working with Emerging markets, biologic products and/or in the oncology therapeutic area would be an advantage but not essential.
- Excellent organizational skills and ability to work on several projects with tight timelines.
- Excellent influencing and negotiation skills
- Excellent communication skills both in writing and verbally
- Methodical attention to detail.
- Positive and solution oriented "can do" attitude and be "hands on" as required
KEY ROLE-RELATED COMPETENCIES
- Proven track record to manage, formulate and execute strategy
- Embrace and thrive in a diverse team
- A driven self-starter
- Able to take ownership and initiative
EDUCATION and/or EXPERIENCE REQUIRED
- Life Science degree.
- A good level of experience in Regulatory Affairs. Direct regulatory experience with International markets is desirable.
- A proven ability to co-ordinate the preparation of a variety of complex regulatory documentation in collaboration with other functions.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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