Novartis Biochemistry Jobs – Biology & Biotech Associate Post
Novartis Biochemistry, Biotechnology, Biology Jobs. Clinical Data Manager jobs for life sciences candidates. Check out all of the details regarding the CDD vacancy in the SANDOZ dept given below:
Novartis Job Details
Job Title: Associate – Development Regulatory Centers (DRC)
Job ID: 283660BR
Location: Hyderabad, AP
Business Unit: Product Dev SZ
Employment Type: Regular
Job Description for Novartis Job:
The key responsibility of this position is to ensure:
- Support DRC Manager/ Specialist for Regulatory filings/dossiers as per established development milestones.
- Take project ownership within DRC for projects with a reduced degree of complexity as well as supports DRC Manager/Specialist for higher complexity projects.
- Prompt regulatory authorization is obtained by appropriate Health Authorities.
Your responsibilities consist of, yet are not restricted to:
- Assist DRC in preparation of regulatory submissions (e.g. AS WELL AS, ANDA, SANDS) along with query responses to health authority concerns throughout development and registration in close cooperation with relevant SDC departments.
- Recognize the needed documentation for global submissions as well as interact expected delivery dates of technological source documents in accordance with project timelines given by project management as well as SDC departments.
- Identify and escalate as appropriate content, quality and/or concerns with source documents, or any other potential authorizing problems that might influence submission quality or timelines, as early as possible.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all worldwide areas as well as for new technical trends.
- Active participation as a member of the development team by contributing to the regulatory strategy, identifying vital issues as well as applying lessons learned.
- Establish and maintain a sound working relationship with all Sandoz Regulatory affairs departments and also SDC groups.
- Support DRC manager/specialist for worldwide regulatory strategy for developments projects with a focus on creativity and innovation, maximizing business benefit balanced with regulatory compliance.
Minimum requirements for Novartis Job:
What you’ll bring to the role:
- Degree in Science (e.g. Bachelors degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equal Desired– Advanced Degree in Science (Bachelors/Masters/Ph. D Chemistry) Fluent English needed (oral as well as written).
- A minimum of 3 years of experience in the pharmaceutical industry (i.e. formulation, analytics, and quality assurance) regulatory affairs liked.
- Working knowledge of chemistry, analytics or pharmaceutical technology. Knowledge of the drug development of process desirable.
- Capacity to seriously evaluate data from a wide range of science disciplines.
- Good knowledge of ICH, EMA, US FDA guidelines and regulatory procedures.
- Capacity to work successfully with extended, multinational project groups as well as coordinate activities simultaneously on several projects under pressure of time as well as work.
- Effective planning, organizational and interpersonal skills.
- Excellent written/spoken communication and negotiation abilities.
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